Clinical trial NCT00963118: Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Official title: Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Angelica keiskei
Glycine max
metabolic syndrome
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Academy of Agricultural science, Korea
name: Sungkyunkwan University
First posted: 2009-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: plasma total antioxidant performance, DNA damage and DNA methylation
timeFrame: baseline, 2 & 4 wks after supplementation
Secondary outcomes:
measure: hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)
timeFrame: Baseline, 2 & 4 wks after supplementation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
References: