Cardiovascular Disease, Oxidative Stress
Conditions
Keywords
aronia, LDL cholesterol, polyphenols, bioavailability, oxidative stress
Brief summary
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.
Detailed description
More than 31% of Connecticut adults are former smokers, which may contribute to the high cardiovascular disease (CVD) risk in this state. Atherosclerosis, a hallmark of CVD, is a progressive life-long process. Chronic cigarette smoking increases atherosclerosis and CVD risk. While smoking cessation may lower CVD risk, former smokers still are at high CVD risk. The mechanisms by which smoking accelerates atherosclerosis formation are not fully understood. This knowledge gap prevents development of informed interventions to reduce CVD risk in former smokers. Previous work suggests smoking increases oxidative stress and leads to elevated CVD risk. Former smokers also have decreased antioxidants and markers of vascular function in the circulation, suggesting that despite cessation, smoking has a lingering adverse effect on CVD protective mechanisms. Chokeberry (Aronia melanocarpa) is a native Connecticut plant rich in polyphenol antioxidants and is a promising intervention for reducing CVD risk in former smokers. Chokeberries have diverse polyphenols such as anthocyanins, proanthocyanidins, resveratrol, quercetin, and chlorogenic acid. Chokeberry consumption improves dyslipidemia, inhibits inflammation, and reduces oxidative stress in humans and animals, all of which could contribute to the prevention of CVD in former smokers. Therefore, our central hypothesis is that dietary chokeberry polyphenols reduce CVD risk in former smokers by improving lipid profiles and inhibiting inflammation and oxidative stress. Our long-term goal is to define the mechanisms by which polyphenol antioxidants mitigate CVD risk. The overall goal of this project is to conduct a randomized placebo-controlled clinical trial to evaluate the cardio-protective effects of dietary chokeberry polyphenols in former smokers. Our objectives are to determine 1) the effect of chokeberry polyphenols on plasma cholesterol and triglyceride levels and on gene expression involved in cholesterol metabolism; 2) the extent to which chokeberry improves antioxidant and vascular function in former smokers; and 3) the association of bioavailability of chokeberry polyphenols to changes in biomarkers of CVD risk. Successful completion of this work will result in improved understanding of the role of dietary berry polyphenols to regulate lipid metabolism, inflammation and oxidative stress. Thus, this study will be an important step to developing dietary recommendations for individuals predisposed to CVD risk, particularly former smokers.
Interventions
DIETARY_SUPPLEMENTChokeberry Extract
Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
DIETARY_SUPPLEMENTPlacebo capsule
Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
DIETARY_SUPPLEMENTChokeberry extract capsule, acute
Chokeberry extract capsule, 2 x 250 mg, one-time dose.
Sponsors
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Former smoker (previously smoked ≥3 cigarettes/day for at least 1 year, cessation for at least 6 months * Healthy male or female between 18-65 y * Serum clinical ranges no more than mildly elevated (serum cholesterol \<240 mg/dL) and serum triglyceride (\<150 mg/dL) * Resting blood pressure \<140/90 mm Hg * Stable body weight (±5 lb) for last 2 months * BMI ranges within normal and overweight (18.5-39 kg/m2) * Willing to maintain normal exercise level (\<7 h/wk) * Willing to avoid exercise 24 h prior to blood sampling * Willing to ingest a dietary chokeberry supplement or placebo (500 mg/d) daily for 12 wks.
Exclusion criteria
* Previous diagnoses of CVD, diabetes, or arthritis (except for osteo-arthritis) * Currently being treated for cancer (i.e., chemotherapy, radiation therapy) * Women with prescribed estrogen replacement therapy * Practicing slimming diet * Practicing vegetarian diet * Currently taking vitamin or mineral supplements or plant pills * Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day or a total of 12/week for men or 1 drink/day or a total of 7/week for women)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | Baseline, 6 weeks, 12 weeks of intervention | Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL-cholesterol | 6 and 12 weeks after supplementation | Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Triglycerides | 6 and 12 weeks after supplementation | Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Resting Systolic Blood Pressure | Baseline, 6 weeks, and 12 weeks following intervention | Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Resting Diastolic Blood Pressure | Baseline, 6 weeks, and 12 weeks following intervention | Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Urinary F2-isoprostanes | Baseline and 12 weeks following intervention | Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | Baseline, 12 wk | Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| LDL Receptor (LDLR) | Change from baseline at 12 weeks | Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| LDL Receptor (LDLR) Protein | Baseline, 12 weeks | Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose | Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule). |
| Urinary Excretion of Polyphenols | 0 to 24 h after consumption of extract | Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only. |
| Adiponectin | Baseline, 6 weeks, 12 weeks | Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Interleukin-1 Beta | Baseline, 6 weeks, 12 weeks | Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Interleukin-6 | Baseline, 6 weeks, 12 weeks | Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Monocyte Chemoattractant Protein-1 | Baseline, 6 weeks, 12 weeks | Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Tumor Necrosis Factor-alpha | Baseline, 6 weeks, 12 weeks | Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Total Cholesterol | 6 and 12 weeks after supplementation | Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Intercellular Adhesion Molecule 1 | Baseline, 6 weeks, 12 weeks | Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Soluble Vascular Cell Adhesion Molecule 1 | Baseline, 6 weeks, 12 weeks | Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| P-selectin | Baseline, 6 weeks, 12 weeks | Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Total Antioxidant Capacity | Baseline, 6 weeks, 12 weeks | Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Catalase Activity | Baseline, 6 weeks, 12 weeks | Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Glutathione Peroxidase Activity | Baseline, 6 weeks, 12 weeks | Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Superoxide Dismutase Activity | Baseline, 6 weeks, 12 weeks | Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Urinary Polyphenol Excretion | 12 weeks | Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Baseline, 12 weeks | Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Energy Intake | Baseline, 12 weeks | Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Energy-adjusted Micronutrient Intake | Baseline, 12 weeks | Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Polyphenol Intake | Baseline, 12 weeks | Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Intake of Dietary Antioxidant Capacity | Baseline, 12 weeks | Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Energy-adjusted Vitamin A Intake | Baseline, 12 weeks | Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| C-reactive Protein | Baseline, 6 weeks, 12 weeks | Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Color-matched Rice Powder Pill Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | 24 |
| Chokeberry Extract Capsule Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. | 25 |
| Chokeberry Extract Capsule (Acute) Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. | 6 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Chokeberry Extract Capsule (Acute) | Chokeberry Extract Capsule | Color-matched Rice Powder Pill | Total |
|---|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 12.8 | 32.6 years STANDARD_DEVIATION 12.7 | 37.4 years STANDARD_DEVIATION 14.8 | 34.9 years STANDARD_DEVIATION 13.9 |
| Average years of smoking | 4.8 years STANDARD_DEVIATION 3 | 8.96 years STANDARD_DEVIATION 6.68 | 14.9 years STANDARD_DEVIATION 11.9 | 11.9 years STANDARD_DEVIATION 10 |
| BMI | 24.1 kg/m^2 STANDARD_DEVIATION 2.3 | 25.7 kg/m^2 STANDARD_DEVIATION 5 | 27.2 kg/m^2 STANDARD_DEVIATION 4.7 | 26.5 kg/m^2 STANDARD_DEVIATION 4.9 |
| Degree of past smoking 11-15 cigarettes/day | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
| Degree of past smoking 16-20 cigarettes/day | 0 Participants | 6 Participants | 11 Participants | 17 Participants |
| Degree of past smoking >20 cigarettes/day | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Degree of past smoking 3-5 cigarettes/day | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Degree of past smoking 6-10 cigarettes/day | 1 Participants | 7 Participants | 4 Participants | 12 Participants |
| Diastolic blood pressure | 73.3 mmHg STANDARD_DEVIATION 4.7 | 75.3 mmHg STANDARD_DEVIATION 12 | 76.0 mmHg STANDARD_DEVIATION 10.4 | 75.6 mmHg STANDARD_DEVIATION 11 |
| HDL-cholesterol | 54.8 mg/dL STANDARD_DEVIATION 15.7 | 26.8 mg/dL STANDARD_DEVIATION 7.6 | 28.7 mg/dL STANDARD_DEVIATION 6.1 | 27.6 mg/dL STANDARD_DEVIATION 6.9 |
| Height | 1.74 m STANDARD_DEVIATION 0.97 | 1.71 m STANDARD_DEVIATION 0.83 | 1.73 m STANDARD_DEVIATION 0.92 | 1.72 m STANDARD_DEVIATION 0.87 |
| LDL-cholesterol | 99.2 mg/dL STANDARD_DEVIATION 19.2 | 175 mg/dL STANDARD_DEVIATION 54 | 158 mg/dL STANDARD_DEVIATION 30 | 168 mg/dL STANDARD_DEVIATION 44 |
| Sex: Female, Male Female | 3 Participants | 12 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 13 Participants | 11 Participants | 27 Participants |
| Systolic blood pressure | 111.3 mmHg STANDARD_DEVIATION 7.7 | 117 mmHg STANDARD_DEVIATION 16 | 121 mmHg STANDARD_DEVIATION 14 | 119 mmHg STANDARD_DEVIATION 15 |
| Total cholesterol | 160 mg/dL STANDARD_DEVIATION 30 | 220 mg/dL STANDARD_DEVIATION 63 | 203 mg/dL STANDARD_DEVIATION 36 | 213 mg/dL STANDARD_DEVIATION 51 |
| Total cholesterol/HDL cholesterol | 3.2 dimensionless ratio STANDARD_DEVIATION 0.7 | 8.5 dimensionless ratio STANDARD_DEVIATION 2.7 | 7.3 dimensionless ratio STANDARD_DEVIATION 1.5 | 8.0 dimensionless ratio STANDARD_DEVIATION 2.3 |
| Triglycerides | 69.2 mg/dL STANDARD_DEVIATION 27.1 | 89.6 mg/dL STANDARD_DEVIATION 45.4 | 82.1 mg/dL STANDARD_DEVIATION 37.3 | 86.3 mg/dL STANDARD_DEVIATION 41 |
| Waist circumference | 79.4 cm STANDARD_DEVIATION 8.4 | 90.9 cm STANDARD_DEVIATION 35.1 | 86.0 cm STANDARD_DEVIATION 17.1 | 88.5 cm STANDARD_DEVIATION 27.6 |
| Weight | 72.8 kg STANDARD_DEVIATION 9.5 | 77.2 kg STANDARD_DEVIATION 21.1 | 81.5 kg STANDARD_DEVIATION 17.2 | 79.3 kg STANDARD_DEVIATION 19.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 | 0 / 6 |
| other Total, other adverse events | 0 / 28 | 0 / 28 | 0 / 6 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 6 |
Outcome results
Primary
LDL Cholesterol
Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks of intervention
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | LDL Cholesterol | 6 weeks | 0.9 mg/dL | Standard Error 4.2 |
| Color-matched Rice Powder Pill | LDL Cholesterol | 12 weeks | -0.4 mg/dL | Standard Error 5.9 |
| Chokeberry Extract Capsule | LDL Cholesterol | 6 weeks | -12.6 mg/dL | Standard Error 5.3 |
| Chokeberry Extract Capsule | LDL Cholesterol | 12 weeks | -18.5 mg/dL | Standard Error 7.8 |
Secondary
3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)
Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 wk
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | Baseline | 0.90 relative expression (HMGR/GAPDH) | Standard Error 0.06 |
| Color-matched Rice Powder Pill | 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | 12 weeks | 1.16 relative expression (HMGR/GAPDH) | Standard Error 0.28 |
| Chokeberry Extract Capsule | 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | Baseline | 0.91 relative expression (HMGR/GAPDH) | Standard Error 0.06 |
| Chokeberry Extract Capsule | 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | 12 weeks | 0.79 relative expression (HMGR/GAPDH) | Standard Error 0.12 |
Secondary
Adiponectin
Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Adiponectin | Baseline | 13.2 micrograms/mL | Standard Error 1.9 |
| Color-matched Rice Powder Pill | Adiponectin | 6 weeks | 14.2 micrograms/mL | Standard Error 2 |
| Color-matched Rice Powder Pill | Adiponectin | 12 weeks | 12.5 micrograms/mL | Standard Error 1.6 |
| Chokeberry Extract Capsule | Adiponectin | Baseline | 12.8 micrograms/mL | Standard Error 1.5 |
| Chokeberry Extract Capsule | Adiponectin | 6 weeks | 13.8 micrograms/mL | Standard Error 1.7 |
| Chokeberry Extract Capsule | Adiponectin | 12 weeks | 13.2 micrograms/mL | Standard Error 1.5 |
Secondary
Catalase Activity
Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Catalase Activity | Baseline | 41.7 nmol/min/mL | Standard Error 1.4 |
| Color-matched Rice Powder Pill | Catalase Activity | 6 weeks | 35.5 nmol/min/mL | Standard Error 1.2 |
| Color-matched Rice Powder Pill | Catalase Activity | 12 weeks | 41.7 nmol/min/mL | Standard Error 2.3 |
| Chokeberry Extract Capsule | Catalase Activity | Baseline | 41.1 nmol/min/mL | Standard Error 2.1 |
| Chokeberry Extract Capsule | Catalase Activity | 6 weeks | 38.7 nmol/min/mL | Standard Error 1.5 |
| Chokeberry Extract Capsule | Catalase Activity | 12 weeks | 41.2 nmol/min/mL | Standard Error 1.8 |
Secondary
C-reactive Protein
Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | C-reactive Protein | Baseline | 2.54 pg/mL | Standard Error 0.6 |
| Color-matched Rice Powder Pill | C-reactive Protein | 6 weeks | 2.18 pg/mL | Standard Error 0.42 |
| Color-matched Rice Powder Pill | C-reactive Protein | 12 weeks | 2.24 pg/mL | Standard Error 0.38 |
| Chokeberry Extract Capsule | C-reactive Protein | Baseline | 2.01 pg/mL | Standard Error 0.34 |
| Chokeberry Extract Capsule | C-reactive Protein | 6 weeks | 2.32 pg/mL | Standard Error 0.39 |
| Chokeberry Extract Capsule | C-reactive Protein | 12 weeks | 2.29 pg/mL | Standard Error 0.49 |
Secondary
Energy-adjusted Micronutrient Intake
Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Energy-adjusted Micronutrient Intake | Vitamin D | 5.0 mg/day | Standard Error 0.9 |
| Color-matched Rice Powder Pill | Energy-adjusted Micronutrient Intake | Vitamin E | 10.6 mg/day | Standard Error 1.1 |
| Color-matched Rice Powder Pill | Energy-adjusted Micronutrient Intake | Sodium | 3490 mg/day | Standard Error 160 |
| Color-matched Rice Powder Pill | Energy-adjusted Micronutrient Intake | Calcium | 947 mg/day | Standard Error 58 |
| Color-matched Rice Powder Pill | Energy-adjusted Micronutrient Intake | Iron | 16.9 mg/day | Standard Error 1.3 |
| Color-matched Rice Powder Pill | Energy-adjusted Micronutrient Intake | Vitamin C | 80.9 mg/day | Standard Error 12.9 |
| Chokeberry Extract Capsule | Energy-adjusted Micronutrient Intake | Iron | 16.9 mg/day | Standard Error 1.2 |
| Chokeberry Extract Capsule | Energy-adjusted Micronutrient Intake | Vitamin D | 7.1 mg/day | Standard Error 0.8 |
| Chokeberry Extract Capsule | Energy-adjusted Micronutrient Intake | Calcium | 1070 mg/day | Standard Error 50 |
| Chokeberry Extract Capsule | Energy-adjusted Micronutrient Intake | Vitamin E | 10.8 mg/day | Standard Error 1.1 |
| Chokeberry Extract Capsule | Energy-adjusted Micronutrient Intake | Vitamin C | 90.9 mg/day | Standard Error 12.1 |
| Chokeberry Extract Capsule | Energy-adjusted Micronutrient Intake | Sodium | 3480 mg/day | Standard Error 150 |
Secondary
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Carbohydrate | 238 g/day | Standard Error 9 |
| Color-matched Rice Powder Pill | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Protein | 89.2 g/day | Standard Error 3.3 |
| Color-matched Rice Powder Pill | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Fat | 27.8 g/day | Standard Error 4 |
| Color-matched Rice Powder Pill | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Fiber | 23.5 g/day | Standard Error 1.6 |
| Chokeberry Extract Capsule | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Fiber | 21.0 g/day | Standard Error 1.5 |
| Chokeberry Extract Capsule | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Carbohydrate | 241 g/day | Standard Error 9 |
| Chokeberry Extract Capsule | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Fat | 77.6 g/day | Standard Error 29.5 |
| Chokeberry Extract Capsule | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Protein | 90.3 g/day | Standard Error 3.1 |
Secondary
Energy-adjusted Vitamin A Intake
Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Color-matched Rice Powder Pill | Energy-adjusted Vitamin A Intake | 3280 retinol equivalent mcg/day | Standard Error 740 |
| Chokeberry Extract Capsule | Energy-adjusted Vitamin A Intake | 2690 retinol equivalent mcg/day | Standard Error 690 |
Secondary
Energy Intake
Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Color-matched Rice Powder Pill | Energy Intake | 2230 kcal/d | Standard Error 735 |
| Chokeberry Extract Capsule | Energy Intake | 1950 kcal/d | Standard Error 530 |
Secondary
Glutathione Peroxidase Activity
Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Glutathione Peroxidase Activity | Baseline | 2550 nmol/min/mL | Standard Error 140 |
| Color-matched Rice Powder Pill | Glutathione Peroxidase Activity | 6 weeks | 2560 nmol/min/mL | Standard Error 130 |
| Color-matched Rice Powder Pill | Glutathione Peroxidase Activity | 12 weeks | 2470 nmol/min/mL | Standard Error 110 |
| Chokeberry Extract Capsule | Glutathione Peroxidase Activity | Baseline | 2550 nmol/min/mL | Standard Error 140 |
| Chokeberry Extract Capsule | Glutathione Peroxidase Activity | 6 weeks | 2500 nmol/min/mL | Standard Error 160 |
| Chokeberry Extract Capsule | Glutathione Peroxidase Activity | 12 weeks | 2650 nmol/min/mL | Standard Error 190 |
Secondary
HDL-cholesterol
Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: 6 and 12 weeks after supplementation
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | HDL-cholesterol | Baseline | 28.8 mg/dL | Standard Error 1.3 |
| Color-matched Rice Powder Pill | HDL-cholesterol | 6 weeks (change from baseline) | -0.9 mg/dL | Standard Error 1 |
| Color-matched Rice Powder Pill | HDL-cholesterol | 12 weeks (change from baseline) | -0.7 mg/dL | Standard Error 1.4 |
| Chokeberry Extract Capsule | HDL-cholesterol | Baseline | 26.8 mg/dL | Standard Error 1.5 |
| Chokeberry Extract Capsule | HDL-cholesterol | 6 weeks (change from baseline) | 0.2 mg/dL | Standard Error 0.8 |
| Chokeberry Extract Capsule | HDL-cholesterol | 12 weeks (change from baseline) | 0.2 mg/dL | Standard Error 0.8 |
Secondary
Intake of Dietary Antioxidant Capacity
Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Color-matched Rice Powder Pill | Intake of Dietary Antioxidant Capacity | 417 Vitamin C equivalents | Standard Error 95 |
| Chokeberry Extract Capsule | Intake of Dietary Antioxidant Capacity | 292 Vitamin C equivalents | Standard Error 89 |
Secondary
Intercellular Adhesion Molecule 1
Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Intercellular Adhesion Molecule 1 | Baseline | 97.1 ng/mL | Standard Error 7.2 |
| Color-matched Rice Powder Pill | Intercellular Adhesion Molecule 1 | 6 weeks | 97.6 ng/mL | Standard Error 7.2 |
| Color-matched Rice Powder Pill | Intercellular Adhesion Molecule 1 | 12 weeks | 100 ng/mL | Standard Error 8 |
| Chokeberry Extract Capsule | Intercellular Adhesion Molecule 1 | Baseline | 96.6 ng/mL | Standard Error 5.4 |
| Chokeberry Extract Capsule | Intercellular Adhesion Molecule 1 | 6 weeks | 99.4 ng/mL | Standard Error 5.7 |
| Chokeberry Extract Capsule | Intercellular Adhesion Molecule 1 | 12 weeks | 97.5 ng/mL | Standard Error 5.8 |
Secondary
Interleukin-1 Beta
Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Interleukin-1 Beta | Baseline | 9.3 pg/mL | Standard Error 2.4 |
| Color-matched Rice Powder Pill | Interleukin-1 Beta | 6 weeks | 9.5 pg/mL | Standard Error 2.7 |
| Color-matched Rice Powder Pill | Interleukin-1 Beta | 12 weeks | 10.1 pg/mL | Standard Error 3 |
| Chokeberry Extract Capsule | Interleukin-1 Beta | Baseline | 16.2 pg/mL | Standard Error 8.6 |
| Chokeberry Extract Capsule | Interleukin-1 Beta | 6 weeks | 17.0 pg/mL | Standard Error 9.7 |
| Chokeberry Extract Capsule | Interleukin-1 Beta | 12 weeks | 14.7 pg/mL | Standard Error 7.4 |
Secondary
Interleukin-6
Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Interleukin-6 | Baseline | 1.94 pg/mL | Standard Error 0.34 |
| Color-matched Rice Powder Pill | Interleukin-6 | 6 weeks | 1.87 pg/mL | Standard Error 0.38 |
| Color-matched Rice Powder Pill | Interleukin-6 | 12 weeks | 1.76 pg/mL | Standard Error 0.29 |
| Chokeberry Extract Capsule | Interleukin-6 | Baseline | 4.68 pg/mL | Standard Error 1.34 |
| Chokeberry Extract Capsule | Interleukin-6 | 6 weeks | 5.16 pg/mL | Standard Error 1.54 |
| Chokeberry Extract Capsule | Interleukin-6 | 12 weeks | 5.34 pg/mL | Standard Error 1.52 |
Secondary
LDL Receptor (LDLR)
Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Change from baseline at 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | LDL Receptor (LDLR) | Baseline | 0.90 relative expression (LDLR/GAPDH) | Standard Error 0.07 |
| Color-matched Rice Powder Pill | LDL Receptor (LDLR) | 12 weeks | 0.93 relative expression (LDLR/GAPDH) | Standard Error 0.22 |
| Chokeberry Extract Capsule | LDL Receptor (LDLR) | Baseline | 0.84 relative expression (LDLR/GAPDH) | Standard Error 0.07 |
| Chokeberry Extract Capsule | LDL Receptor (LDLR) | 12 weeks | 0.88 relative expression (LDLR/GAPDH) | Standard Error 0.26 |
Secondary
LDL Receptor (LDLR) Protein
Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | LDL Receptor (LDLR) Protein | Baseline | 1.71 relative expression (LDLR/β-actin) | Standard Error 0.33 |
| Color-matched Rice Powder Pill | LDL Receptor (LDLR) Protein | 12 weeks | 2.47 relative expression (LDLR/β-actin) | Standard Error 0.8 |
| Chokeberry Extract Capsule | LDL Receptor (LDLR) Protein | Baseline | 1.45 relative expression (LDLR/β-actin) | Standard Error 0.06 |
| Chokeberry Extract Capsule | LDL Receptor (LDLR) Protein | 12 weeks | 1.45 relative expression (LDLR/β-actin) | Standard Error 0.64 |
Secondary
Monocyte Chemoattractant Protein-1
Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Monocyte Chemoattractant Protein-1 | 12 weeks | 91 pg/mL | Standard Error 5 |
| Color-matched Rice Powder Pill | Monocyte Chemoattractant Protein-1 | Baseline | 97 pg/mL | Standard Error 6 |
| Color-matched Rice Powder Pill | Monocyte Chemoattractant Protein-1 | 6 weeks | 96 pg/mL | Standard Error 5 |
| Chokeberry Extract Capsule | Monocyte Chemoattractant Protein-1 | Baseline | 133 pg/mL | Standard Error 31 |
| Chokeberry Extract Capsule | Monocyte Chemoattractant Protein-1 | 6 weeks | 167 pg/mL | Standard Error 43 |
| Chokeberry Extract Capsule | Monocyte Chemoattractant Protein-1 | 12 weeks | 141 pg/mL | Standard Error 27 |
Secondary
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).
Time frame: 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose
Population: Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | Protocatechuic acid | 0.054 micrograms x h/mL | Standard Error 0.013 |
| Color-matched Rice Powder Pill | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | Hippuric acid | 22.350 micrograms x h/mL | Standard Error 4.441 |
| Color-matched Rice Powder Pill | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | 3-(4-Hydroxyphenyl)propionic acid | 2.725 micrograms x h/mL | Standard Error 2.391 |
| Color-matched Rice Powder Pill | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | Cyanidin-3-O-glucoside | 0.462 micrograms x h/mL | Standard Error 0.17 |
| Color-matched Rice Powder Pill | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | Peonidin-3-O-galactoside | 0.627 micrograms x h/mL | Standard Error 0.198 |
Secondary
Polyphenol Intake
Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 12 weeks
Population: Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Polyphenol Intake | Anthocyanins | 18.2 mg/day | Standard Error 5.2 |
| Color-matched Rice Powder Pill | Polyphenol Intake | Proanthocyanidins | 222 mg/day | Standard Error 162 |
| Color-matched Rice Powder Pill | Polyphenol Intake | Isoflavones | 3.9 mg/day | Standard Error 2.7 |
| Color-matched Rice Powder Pill | Polyphenol Intake | Flavanols | 73.9 mg/day | Standard Error 20 |
| Color-matched Rice Powder Pill | Polyphenol Intake | Flavones | 54.1 mg/day | Standard Error 29.1 |
| Color-matched Rice Powder Pill | Polyphenol Intake | Flavanones | 28.8 mg/day | Standard Error 11.4 |
| Color-matched Rice Powder Pill | Polyphenol Intake | Flavan-3-ols | 20.6 mg/day | Standard Error 7.4 |
| Chokeberry Extract Capsule | Polyphenol Intake | Flavanols | 81.7 mg/day | Standard Error 18.7 |
| Chokeberry Extract Capsule | Polyphenol Intake | Anthocyanins | 26.6 mg/day | Standard Error 4.8 |
| Chokeberry Extract Capsule | Polyphenol Intake | Flavones | 50.3 mg/day | Standard Error 27.2 |
| Chokeberry Extract Capsule | Polyphenol Intake | Proanthocyanidins | 418 mg/day | Standard Error 150 |
| Chokeberry Extract Capsule | Polyphenol Intake | Flavan-3-ols | 26.0 mg/day | Standard Error 6.9 |
| Chokeberry Extract Capsule | Polyphenol Intake | Isoflavones | 8.5 mg/day | Standard Error 2.6 |
| Chokeberry Extract Capsule | Polyphenol Intake | Flavanones | 22.4 mg/day | Standard Error 10.7 |
Secondary
P-selectin
Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | P-selectin | 12 weeks | 131 ng/mL | Standard Error 11 |
| Color-matched Rice Powder Pill | P-selectin | 6 weeks | 111 ng/mL | Standard Error 11 |
| Color-matched Rice Powder Pill | P-selectin | Baseline | 130 ng/mL | Standard Error 13 |
| Chokeberry Extract Capsule | P-selectin | 6 weeks | 127 ng/mL | Standard Error 12 |
| Chokeberry Extract Capsule | P-selectin | Baseline | 124 ng/mL | Standard Error 12 |
| Chokeberry Extract Capsule | P-selectin | 12 weeks | 145 ng/mL | Standard Error 17 |
Secondary
Resting Diastolic Blood Pressure
Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, and 12 weeks following intervention
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Resting Diastolic Blood Pressure | Baseline | 76.0 mmHg | Standard Error 2.1 |
| Color-matched Rice Powder Pill | Resting Diastolic Blood Pressure | 6 weeks (change from baseline) | -1.2 mmHg | Standard Error 2.4 |
| Color-matched Rice Powder Pill | Resting Diastolic Blood Pressure | 12 weeks (change from baseline) | -1.1 mmHg | Standard Error 1.7 |
| Chokeberry Extract Capsule | Resting Diastolic Blood Pressure | Baseline | 75.3 mmHg | Standard Error 2.4 |
| Chokeberry Extract Capsule | Resting Diastolic Blood Pressure | 6 weeks (change from baseline) | 5.0 mmHg | Standard Error 1.3 |
| Chokeberry Extract Capsule | Resting Diastolic Blood Pressure | 12 weeks (change from baseline) | 2.0 mmHg | Standard Error 1.5 |
Secondary
Resting Systolic Blood Pressure
Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, and 12 weeks following intervention
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Resting Systolic Blood Pressure | Baseline | 121 mmHg | Standard Error 3 |
| Color-matched Rice Powder Pill | Resting Systolic Blood Pressure | 6 weeks (change from baseline) | -0.8 mmHg | Standard Error 1.5 |
| Color-matched Rice Powder Pill | Resting Systolic Blood Pressure | 12 weeks (change from baseline) | 0.2 mmHg | Standard Error 2.9 |
| Chokeberry Extract Capsule | Resting Systolic Blood Pressure | Baseline | 117 mmHg | Standard Error 3 |
| Chokeberry Extract Capsule | Resting Systolic Blood Pressure | 6 weeks (change from baseline) | 2.8 mmHg | Standard Error 1.7 |
| Chokeberry Extract Capsule | Resting Systolic Blood Pressure | 12 weeks (change from baseline) | 1.2 mmHg | Standard Error 2.4 |
Secondary
Soluble Vascular Cell Adhesion Molecule 1
Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Soluble Vascular Cell Adhesion Molecule 1 | Baseline | 585 ng/mL | Standard Deviation 23 |
| Color-matched Rice Powder Pill | Soluble Vascular Cell Adhesion Molecule 1 | 6 weeks | 604 ng/mL | Standard Deviation 23 |
| Color-matched Rice Powder Pill | Soluble Vascular Cell Adhesion Molecule 1 | 12 weeks | 604 ng/mL | Standard Deviation 26 |
| Chokeberry Extract Capsule | Soluble Vascular Cell Adhesion Molecule 1 | Baseline | 601 ng/mL | Standard Deviation 31 |
| Chokeberry Extract Capsule | Soluble Vascular Cell Adhesion Molecule 1 | 6 weeks | 622 ng/mL | Standard Deviation 31 |
| Chokeberry Extract Capsule | Soluble Vascular Cell Adhesion Molecule 1 | 12 weeks | 599 ng/mL | Standard Deviation 27 |
Secondary
Superoxide Dismutase Activity
Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Superoxide Dismutase Activity | 6 weeks | 1190 units/mL | Standard Error 50 |
| Color-matched Rice Powder Pill | Superoxide Dismutase Activity | 12 weeks | 1160 units/mL | Standard Error 60 |
| Color-matched Rice Powder Pill | Superoxide Dismutase Activity | Baseline | 1190 units/mL | Standard Error 50 |
| Chokeberry Extract Capsule | Superoxide Dismutase Activity | 6 weeks | 1160 units/mL | Standard Error 40 |
| Chokeberry Extract Capsule | Superoxide Dismutase Activity | 12 weeks | 1160 units/mL | Standard Error 40 |
| Chokeberry Extract Capsule | Superoxide Dismutase Activity | Baseline | 1180 units/mL | Standard Error 40 |
Secondary
Total Antioxidant Capacity
Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Total Antioxidant Capacity | Baseline | 210 micrograms vitamin C equivalents/mL | Standard Error 4 |
| Color-matched Rice Powder Pill | Total Antioxidant Capacity | 6 weeks | 214 micrograms vitamin C equivalents/mL | Standard Error 3 |
| Color-matched Rice Powder Pill | Total Antioxidant Capacity | 12 weeks | 209 micrograms vitamin C equivalents/mL | Standard Error 4 |
| Chokeberry Extract Capsule | Total Antioxidant Capacity | Baseline | 208 micrograms vitamin C equivalents/mL | Standard Error 3 |
| Chokeberry Extract Capsule | Total Antioxidant Capacity | 6 weeks | 211 micrograms vitamin C equivalents/mL | Standard Error 3 |
| Chokeberry Extract Capsule | Total Antioxidant Capacity | 12 weeks | 207 micrograms vitamin C equivalents/mL | Standard Error 4 |
Secondary
Total Cholesterol
Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: 6 and 12 weeks after supplementation
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Total Cholesterol | Baseline | 203 mg/dL | Standard Error 7 |
| Color-matched Rice Powder Pill | Total Cholesterol | 6 weeks (change from baseline) | -0.1 mg/dL | Standard Error 4.6 |
| Color-matched Rice Powder Pill | Total Cholesterol | 12 weeks (change from baseline) | -1.3 mg/dL | Standard Error 6.4 |
| Chokeberry Extract Capsule | Total Cholesterol | Baseline | 220 mg/dL | Standard Error 13 |
| Chokeberry Extract Capsule | Total Cholesterol | 6 weeks (change from baseline) | 1.4 mg/dL | Standard Error 2.5 |
| Chokeberry Extract Capsule | Total Cholesterol | 12 weeks (change from baseline) | -17.9 mg/dL | Standard Error 7.6 |
Secondary
Triglycerides
Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: 6 and 12 weeks after supplementation
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Triglycerides | Baseline | 82.1 mg/dL | Standard Error 7.6 |
| Color-matched Rice Powder Pill | Triglycerides | 6 weeks (change from baseline) | -0.6 mg/dL | Standard Error 2.7 |
| Color-matched Rice Powder Pill | Triglycerides | 12 weeks (change from baseline) | -1.0 mg/dL | Standard Error 5.9 |
| Chokeberry Extract Capsule | Triglycerides | Baseline | 89.6 mg/dL | Standard Error 9 |
| Chokeberry Extract Capsule | Triglycerides | 6 weeks (change from baseline) | 1.0 mg/dL | Standard Error 5.9 |
| Chokeberry Extract Capsule | Triglycerides | 12 weeks (change from baseline) | 2.0 mg/dL | Standard Error 8.5 |
Secondary
Tumor Necrosis Factor-alpha
Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline, 6 weeks, 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Tumor Necrosis Factor-alpha | 6 weeks | 4.70 pg/mL | Standard Error 1.89 |
| Color-matched Rice Powder Pill | Tumor Necrosis Factor-alpha | 12 weeks | 4.86 pg/mL | Standard Error 1.85 |
| Color-matched Rice Powder Pill | Tumor Necrosis Factor-alpha | Baseline | 4.36 pg/mL | Standard Error 1.83 |
| Chokeberry Extract Capsule | Tumor Necrosis Factor-alpha | 12 weeks | 6.10 pg/mL | Standard Error 1.72 |
| Chokeberry Extract Capsule | Tumor Necrosis Factor-alpha | 6 weeks | 6.44 pg/mL | Standard Error 1.83 |
| Chokeberry Extract Capsule | Tumor Necrosis Factor-alpha | Baseline | 5.90 pg/mL | Standard Error 1.63 |
Secondary
Urinary Excretion of Polyphenols
Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.
Time frame: 0 to 24 h after consumption of extract
Population: Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | Protocatechuic acid | 3.682 mg x h/mg creatinine | Standard Error 0.587 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | 3,4-dihyrdoxyphenylacetic acid | 11.426 mg x h/mg creatinine | Standard Error 0.881 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | Hippuric acid | 2429.852 mg x h/mg creatinine | Standard Error 360.197 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | 3-(4-hydroxyphenyl)propionic acid | 2.299 mg x h/mg creatinine | Standard Error 0.715 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | Cyanidin-3-O-galactoside | 0.016 mg x h/mg creatinine | Standard Error 0.005 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | Cyanidin-3-O-glucoside | 0.118 mg x h/mg creatinine | Standard Error 0.07 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | Cyanidin-3-O-arabinoside | 0.088 mg x h/mg creatinine | Standard Error 0.031 |
| Color-matched Rice Powder Pill | Urinary Excretion of Polyphenols | Peonidin-3-O-galactoside | 0.053 mg x h/mg creatinine | Standard Error 0.012 |
Secondary
Urinary F2-isoprostanes
Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: Baseline and 12 weeks following intervention
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Color-matched Rice Powder Pill | Urinary F2-isoprostanes | Baseline | 71.0 ng/mmol creatinine | Standard Error 8.1 |
| Color-matched Rice Powder Pill | Urinary F2-isoprostanes | 12 weeks | 81.6 ng/mmol creatinine | Standard Error 7.8 |
| Chokeberry Extract Capsule | Urinary F2-isoprostanes | Baseline | 58.6 ng/mmol creatinine | Standard Error 7 |
| Chokeberry Extract Capsule | Urinary F2-isoprostanes | 12 weeks | 68.4 ng/mmol creatinine | Standard Error 9 |
Secondary
Urinary Polyphenol Excretion
Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time frame: 12 weeks
Population: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Protocatechuic acid | 1.38 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | 3,4-dihydroxyphenylacetic acid | 5.04 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Hippuric acid | 133 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Ferulic acid | 0.68 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | 3-(4-hydroxyphenyl)propionic acid | 3.91 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Cyanidin-3-O-glucoside | 0 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Cyanidin-3-O-galactoside | 0 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Cyanidin-3-O-arabinoside | 0 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Peonidin-3-O-galactoside | 0 mg/mg creatinine |
| Color-matched Rice Powder Pill | Urinary Polyphenol Excretion | Sum anthocyanins | 0.014 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Cyanidin-3-O-arabinoside | 0 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Protocatechuic acid | 1.20 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Cyanidin-3-O-glucoside | 0.00907 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | 3,4-dihydroxyphenylacetic acid | 4.56 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Sum anthocyanins | 0.134 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Hippuric acid | 138 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Cyanidin-3-O-galactoside | 0.00466 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Ferulic acid | 0.71 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | Peonidin-3-O-galactoside | 0.008 mg/mg creatinine |
| Chokeberry Extract Capsule | Urinary Polyphenol Excretion | 3-(4-hydroxyphenyl)propionic acid | 3.36 mg/mg creatinine |