Type 2 Diabetes
Conditions
Keywords
hyperglycemia, hyperinsulinemia
Brief summary
The purpose of the study is to examine whether almond consumption for 3 month will help Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of cardiovascular disease.
Detailed description
Our previous study demonstrated almonds (\ 60 g/d) improved lipid profile, glucoregulation, inflammation, and oxidative stress in 20 Chinese patients with type 2 diabetes mellitus (T2DM). To follow-up and expand this work with a more robust trial, the investigators propose a larger (n = 40), longer-term (90-d) investigation of the effect of almonds (\ 60 g/d) on adipokine regulation, endothelial function, glucoregulation, inflammation, lipid profile, and oxidative stress in Chinese patients with T2DM as compared to a placebo control. The investigators will conduct a 7-mo randomized, cross-over, placebo controlled clinical trial in which all meals will be provided to all subjects (n = 40). During the first 2 weeks (run-in period), all subjects will receive a control diet resembling a typical Taiwan diet, prepared based on the NCEP Step 2 guidelines. During the following 3 mo (Phase I), subjects will be randomized to receive either the control diet or the control diet with whole almonds (\ 60g/d) incorporated to replace 20% calories. After a 2-wk washout period during which all subjects will once again receive the control diet, subjects will receive the opposite diet to the one assigned during the Phase I for the other 3 months (Phase II). The caloric content of each diet will be adjusted to each subjects' energy needs to prevent any change in body weight. The following biomarkers will be determined at the baseline and end of each dietary intervention: Glucoregulation: fasted serum HbA1c, glucose and insulin, postprandial serum glucose and insulin, and urinary C-peptide; Endothelial Function: brachial artery FMD and serum nitric oxide, e-selectin, endothelial-1 (ET-1), and intracellular adhesion molecule-1 (ICAM-1); Adipokine Regulation: serum adiponectin, leptin, and resistin; Inflammation: serum high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, retinol binding protein-4 (RBP-4), and tumor necrosis factor (TNF)-α; Oxidative Stress: urinary isoprostanes (adjusted for creatinine) and serum protein carbonyls and oxidized LDL; and Lipid Profile: serum cholesterol, triglycerides, and apolipoproteins A1 and B.
Interventions
OTHERAlmond diet first, then NCEP Diet
whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake. Subjects were assigned to receive almond diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to NCEP Diet for 12 weeks
OTHERNCEP diet first, then Almond diet
NCEP diet first, then Almond diet. Subjects were assigned to receive NCEP diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to almond diet for 12 weeks
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* aged between 40-70 years, * with BMI = 24-35 kg/m2, * HbA1c 6.5-9 %, and * regular use of oral hypoglycemic agents.
Exclusion criteria
* Use of insulin to control blood glucose * Regular use of oral steroids * Regular use of anti-inflammatory agents (prescribed \[Rx\] or over-the-counter \[OTC\]) * Gain or loss of larger than 5% of body weight in the last 6 months * CVD: coronary artery disease, left ventricular hypertrophy evidenced by echocardiogram, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease, dysautonomia * Gastrointestinal: diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease, inflammatory bowel disease, treatment with acid-lowering drugs * Renal: chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis, diabetic nephropathy, serum creatinine \> 1.5 mg/dL * Endocrine: disease, untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease, hyperuricemia * Rheumatologic: gout, inflammatory arthritis * Active treatment for cancer of any type (except basal cell carcinoma) 1 year * Systolic blood pressure larger than 150 mmHg, and diastolic blood pressure larger than 95 mmHg. * Any history of or known allergies to nuts of any kind * Frequent nut consumption, defined as ≥ 3 oz/wk; however, subjects who are willing to refrain from eating all nuts and nut products for 6 wk prior to their initial visit (Visit 1) may be considered eligible * Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 1) and throughout the entire study may be considered eligible * Usual daily ethanol intake of larger or equal to 2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor) * Illicit drug use * Specific laboratory blood or urine analysis parameters of: creatinine larger than 1.5 mg/dL, ALT and AST larger than 1.5 nmol/L, and urinalysis - hematuria and proteinuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Major Nutrients of NCEP Step 2 Diet and Almond Diets | the entire study, up to 3 months |
| Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| The Calories of NCEP Step 2 Diet and Almond Diets | the entire study, up to 3 months |
| Lipid Composition of NCEP Step 2 Diet and Almond Diets | the entire study, up to 3 months |
| Body Weight at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| HOMA at the Baseline and the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
| Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention | at the baseline and at the end of 3-month dietary intervention |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Almond Diet First, Then NCEP Diet whole almonds to replace 20% daily calorie intake
whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake. | 17 |
| NCEP Diet First, Then Almond Diet follow NCEP step 2 diet
NCEP Step 2 diet: follow NCEP step 2 diet | 16 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (3 Months) | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Almond Diet First, Then NCEP Diet | NCEP Diet First, Then Almond Diet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Gender Female | 12 Participants | 8 Participants | 20 Participants |
| Gender Male | 5 Participants | 8 Participants | 13 Participants |
| Region of Enrollment Taiwan | 17 participants | 16 participants | 33 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 37424 mg.min/dL | Standard Deviation 7681 |
| NCEP Step 2 Diet | Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 36415 mg.min/dL | Standard Deviation 7250 |
| Alm Before | Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 35768 mg.min/dL | Standard Deviation 7379 |
| Alm After | Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 37706 mg.min/dL | Standard Deviation 8490 |
p-value: 0.1101Mixed Models Analysis
Primary
Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 3975 mU.min/L | Standard Deviation 2353 |
| NCEP Step 2 Diet | Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 4690 mU.min/L | Standard Deviation 3327 |
| Alm Before | Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 4055 mU.min/L | Standard Deviation 2964 |
| Alm After | Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention | 4345 mU.min/L | Standard Deviation 2791 |
p-value: 0.557Mixed Models Analysis
Primary
Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Almonds | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | SBP | 124.2 mmHg | Standard Deviation 15.2 |
| Whole Almonds | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | DBP | 74.9 mmHg | Standard Deviation 10.3 |
| NCEP Step 2 Diet | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | DBP | 77.3 mmHg | Standard Deviation 9.84 |
| NCEP Step 2 Diet | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | SBP | 123.6 mmHg | Standard Deviation 18.2 |
| Alm Before | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | SBP | 124.5 mmHg | Standard Deviation 14 |
| Alm Before | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | DBP | 74.9 mmHg | Standard Deviation 10.6 |
| Alm After | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | SBP | 122.1 mmHg | Standard Deviation 13.4 |
| Alm After | Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention | DBP | 76.5 mmHg | Standard Deviation 10.2 |
p-value: 0.9784Mixed Models Analysis
Primary
Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention | 31.6 percentage of body weight | Standard Deviation 8.73 |
| NCEP Step 2 Diet | Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention | 31.4 percentage of body weight | Standard Deviation 9.4 |
| Alm Before | Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention | 31.0 percentage of body weight | Standard Deviation 8.95 |
| Alm After | Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention | 31.7 percentage of body weight | Standard Deviation 8.63 |
p-value: 0.3837Mixed Models Analysis
Primary
Body Weight at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Body Weight at the Baseline and at the End of 3-month Dietary Intervention | 64.7 kg | Standard Deviation 10.8 |
| NCEP Step 2 Diet | Body Weight at the Baseline and at the End of 3-month Dietary Intervention | 64.8 kg | Standard Deviation 11 |
| Alm Before | Body Weight at the Baseline and at the End of 3-month Dietary Intervention | 65.3 kg | Standard Deviation 11 |
| Alm After | Body Weight at the Baseline and at the End of 3-month Dietary Intervention | 64.7 kg | Standard Deviation 10.7 |
p-value: 0.2412Mixed Models Analysis
Primary
Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Almonds | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | sE-Selectin | 43.4 ng/mL | Standard Deviation 20.7 |
| Whole Almonds | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | ICAM-1 | 22.3 ng/mL | Standard Deviation 7.74 |
| NCEP Step 2 Diet | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | ICAM-1 | 22.9 ng/mL | Standard Deviation 7.22 |
| NCEP Step 2 Diet | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | sE-Selectin | 44.0 ng/mL | Standard Deviation 20.2 |
| Alm Before | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | sE-Selectin | 46.1 ng/mL | Standard Deviation 18 |
| Alm Before | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | ICAM-1 | 24.0 ng/mL | Standard Deviation 8.91 |
| Alm After | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | sE-Selectin | 42.3 ng/mL | Standard Deviation 15.5 |
| Alm After | Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention | ICAM-1 | 23.1 ng/mL | Standard Deviation 8.09 |
p-value: 0.1205Mixed Models Analysis
Primary
HOMA at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | HOMA at the Baseline and the End of 3-month Dietary Intervention | 4.00 pg/mL | Standard Deviation 2.08 |
| NCEP Step 2 Diet | HOMA at the Baseline and the End of 3-month Dietary Intervention | 4.24 pg/mL | Standard Deviation 2.7 |
| Alm Before | HOMA at the Baseline and the End of 3-month Dietary Intervention | 3.58 pg/mL | Standard Deviation 1.75 |
| Alm After | HOMA at the Baseline and the End of 3-month Dietary Intervention | 3.98 pg/mL | Standard Deviation 1.98 |
p-value: 0.8328Mixed Models Analysis
Primary
Lipid Composition of NCEP Step 2 Diet and Almond Diets
Time frame: the entire study, up to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Almonds | Lipid Composition of NCEP Step 2 Diet and Almond Diets | PUFA | 22.0 g | Standard Deviation 4.1 |
| Whole Almonds | Lipid Composition of NCEP Step 2 Diet and Almond Diets | MUFA | 30.7 g | Standard Deviation 4 |
| Whole Almonds | Lipid Composition of NCEP Step 2 Diet and Almond Diets | SFA | 11.1 g | Standard Deviation 3.3 |
| NCEP Step 2 Diet | Lipid Composition of NCEP Step 2 Diet and Almond Diets | PUFA | 22.3 g | Standard Deviation 4.5 |
| NCEP Step 2 Diet | Lipid Composition of NCEP Step 2 Diet and Almond Diets | MUFA | 12.7 g | Standard Deviation 3.3 |
| NCEP Step 2 Diet | Lipid Composition of NCEP Step 2 Diet and Almond Diets | SFA | 9.5 g | Standard Deviation 2.6 |
p-value: <0.0001Mixed Models Analysis
Primary
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Almonds | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo A1 | 128.9 g/L | Standard Deviation 23.9 |
| Whole Almonds | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo B | 82.9 g/L | Standard Deviation 22.2 |
| NCEP Step 2 Diet | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo B | 85.8 g/L | Standard Deviation 24.2 |
| NCEP Step 2 Diet | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo A1 | 135.1 g/L | Standard Deviation 23.4 |
| Alm Before | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo A1 | 128.3 g/L | Standard Deviation 22.8 |
| Alm Before | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo B | 84.3 g/L | Standard Deviation 23.3 |
| Alm After | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo A1 | 135.3 g/L | Standard Deviation 24.3 |
| Alm After | Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention | Apo B | 86.7 g/L | Standard Deviation 22.6 |
p-value: 0.7758Mixed Models Analysis
Primary
Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention | 146.5 mg/dL | Standard Deviation 37.9 |
| NCEP Step 2 Diet | Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention | 139.6 mg/dL | Standard Deviation 33.1 |
| Alm Before | Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention | 140.7 mg/dL | Standard Deviation 30.9 |
| Alm After | Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention | 140.3 mg/dL | Standard Deviation 36.8 |
p-value: 0.5868Mixed Models Analysis
Primary
Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention | 11.2 mU/L | Standard Deviation 4.9 |
| NCEP Step 2 Diet | Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention | 12.3 mU/L | Standard Deviation 6 |
| Alm Before | Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention | 10.4 mU/L | Standard Deviation 4.6 |
| Alm After | Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention | 11.8 mU/L | Standard Deviation 5.7 |
p-value: 0.7823Mixed Models Analysis
Primary
Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention | 7.47 percentage of hemoglubin | Standard Deviation 1.12 |
| NCEP Step 2 Diet | Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention | 7.45 percentage of hemoglubin | Standard Deviation 0.8 |
| Alm Before | Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention | 7.51 percentage of hemoglubin | Standard Deviation 0.97 |
| Alm After | Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention | 7.39 percentage of hemoglubin | Standard Deviation 1.05 |
p-value: 0.6263Mixed Models Analysis
Primary
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Almonds | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | HDL | 44.8 mg/dL | Standard Deviation 12.9 |
| Whole Almonds | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | LDL | 97.5 mg/dL | Standard Deviation 29.3 |
| Whole Almonds | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Total cholesterol | 170.7 mg/dL | Standard Deviation 31.9 |
| Whole Almonds | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Triglyceride | 161.1 mg/dL | Standard Deviation 83.7 |
| NCEP Step 2 Diet | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | LDL | 102.9 mg/dL | Standard Deviation 29.2 |
| NCEP Step 2 Diet | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Total cholesterol | 180.6 mg/dL | Standard Deviation 36 |
| NCEP Step 2 Diet | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Triglyceride | 141.2 mg/dL | Standard Deviation 68.3 |
| NCEP Step 2 Diet | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | HDL | 49.7 mg/dL | Standard Deviation 13.4 |
| Alm Before | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Total cholesterol | 175.1 mg/dL | Standard Deviation 36 |
| Alm Before | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | LDL | 100.2 mg/dL | Standard Deviation 29.5 |
| Alm Before | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Triglyceride | 175.1 mg/dL | Standard Deviation 36 |
| Alm Before | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | HDL | 45.2 mg/dL | Standard Deviation 11.9 |
| Alm After | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Triglyceride | 178.9 mg/dL | Standard Deviation 28.4 |
| Alm After | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | LDL | 98.0 mg/dL | Standard Deviation 24.5 |
| Alm After | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | HDL | 48.5 mg/dL | Standard Deviation 12.4 |
| Alm After | Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention | Total cholesterol | 178.9 mg/dL | Standard Deviation 28.4 |
p-value: 0.2786Mixed Models Analysis
Primary
Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention | 59.6 μmol/L | Standard Deviation 35.8 |
| NCEP Step 2 Diet | Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention | 72.1 μmol/L | Standard Deviation 55.3 |
| Alm Before | Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention | 62.5 μmol/L | Standard Deviation 40.9 |
| Alm After | Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention | 50.6 μmol/L | Standard Deviation 26.7 |
p-value: 0.0476Mixed Models Analysis
Primary
Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention | 32.8 U/L | Standard Deviation 9.9 |
| NCEP Step 2 Diet | Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention | 34.8 U/L | Standard Deviation 10.9 |
| Alm Before | Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention | 33.9 U/L | Standard Deviation 10.9 |
| Alm After | Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention | 35.1 U/L | Standard Deviation 9.9 |
p-value: 0.7364Mixed Models Analysis
Primary
Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention | 1.00 nmol/mg | Standard Deviation 0.54 |
| NCEP Step 2 Diet | Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention | 1.06 nmol/mg | Standard Deviation 0.68 |
| Alm Before | Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention | 1.00 nmol/mg | Standard Deviation 0.65 |
| Alm After | Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention | 0.72 nmol/mg | Standard Deviation 0.56 |
p-value: 0.1512Mixed Models Analysis
Primary
Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention | 8.51 μmol/L | Standard Deviation 3.37 |
| NCEP Step 2 Diet | Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention | 9.24 μmol/L | Standard Deviation 5.45 |
| Alm Before | Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention | 8.86 μmol/L | Standard Deviation 4.43 |
| Alm After | Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention | 9.57 μmol/L | Standard Deviation 5.11 |
p-value: 0.8528Mixed Models Analysis
Primary
The Calories of NCEP Step 2 Diet and Almond Diets
Time frame: the entire study, up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | The Calories of NCEP Step 2 Diet and Almond Diets | 1,665.9 kcal | Standard Deviation 153.8 |
| NCEP Step 2 Diet | The Calories of NCEP Step 2 Diet and Almond Diets | 1,643.4 kcal | Standard Deviation 133.6 |
p-value: 0.42Mixed Models Analysis
Primary
The Major Nutrients of NCEP Step 2 Diet and Almond Diets
Time frame: the entire study, up to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Almonds | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Crude protein | 17.5 % of energy | Standard Deviation 1.3 |
| Whole Almonds | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Fat | 38.4 % of energy | Standard Deviation 3.5 |
| Whole Almonds | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Carbohydrate | 47.0 % of energy | Standard Deviation 3.4 |
| NCEP Step 2 Diet | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Crude protein | 17.2 % of energy | Standard Deviation 1.6 |
| NCEP Step 2 Diet | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Fat | 29.2 % of energy | Standard Deviation 3.1 |
| NCEP Step 2 Diet | The Major Nutrients of NCEP Step 2 Diet and Almond Diets | Carbohydrate | 55.7 % of energy | Standard Deviation 4.3 |
p-value: <0.0001Mixed Models Analysis
Primary
Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Almonds | Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention | 12.2 ng/mg creatinine | Standard Deviation 6.19 |
| NCEP Step 2 Diet | Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention | 14.2 ng/mg creatinine | Standard Deviation 9.22 |
| Alm Before | Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention | 11.9 ng/mg creatinine | Standard Deviation 4.24 |
| Alm After | Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention | 12.2 ng/mg creatinine | Standard Deviation 4.68 |
p-value: 0.1995Mixed Models Analysis