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Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963118
Acronym
Biogreen
Enrollment
36
Registered
2009-08-21
Start date
2009-06-30
Completion date
2010-12-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Angelica keiskei, Glycine max, metabolic syndrome

Brief summary

To achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on genomic stability using noble assays. The investigators propose to study the ability of bioactive plant-based food (Nutrition bar made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (\> 50 years, men and postmenopausal women) with and without metabolic syndrome.

Interventions

DIETARY_SUPPLEMENTplant based nutrition bar

Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.

Sponsors

National Academy of Agricultural science, Korea
CollaboratorUNKNOWN
Sungkyunkwan University
CollaboratorOTHER
Tufts University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

healthy control group (n=20) 1. Age: over 50 years old 2. Female subjects must be post-menopausal 3. BMI: 18.5 - 30, waist/hip ratio \< 0.9 for men, \< 0.85 for women 4. TG\<150 mg/dL (1.7 mmol/L) and no medication for TG 5. Total cholesterol \< 200 mg /dL (5.18 mmol/L) and no medication for cholesterol 6. Blood pressure: SBP \< 130 mmHg and DBP \< 85 mmHg and no hypertensive medication 7. Plasma glucose: fasting blood glucose \< 100 mg/dL (5.6 mmol/L) and no diabetes medication Inclusion Criteria: Metabolic syndrome (n=40) 1. Age: over 50 years old 2. BMI: \> 30 or waist/hip ratio \> 0.9 for men, \> 0.85 for women 3. Plus any two of the following four factors: * TG: 150-400 mg/dL (1.7 - 4.52 mmol/L) and/or medication for TG * HDL cholesterol: \<40 mg /dL (1.03 mmol/L) for men, \<50 mg/dL (1.29 mmol/L) for women and/or medication for cholesterol * Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg and/or antihypertensive medication * Plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no diabetes medication

Exclusion criteria

1. Study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption. 2. Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders will be excluded from the study. 3. Exogenous hormone users will be excluded from the study. 4. Moreover, subjects will be non-smokers and will not have taken vitamin or carotenoid supplements for at least 6 weeks prior to the study and throughout the study for both healthy subjects and subjects with metabolic syndrome.

Design outcomes

Primary

MeasureTime frame
plasma total antioxidant performance, DNA damage and DNA methylationbaseline, 2 & 4 wks after supplementation

Secondary

MeasureTime frame
hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)Baseline, 2 & 4 wks after supplementation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026