Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: plant based nutrition bar

• Registration Number: NCT00963118
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycine max	plant based nutrition bar	Glycine max (black soybeans) based nutrition bar
placebo	plant based nutrition bar	Rice powder based nutrition bar
Angelica keiskei	plant based nutrition bar	Angelica keiskei (green leafy vegetable) based nutrition bar
Angelica keiskei + Glycine max	plant based nutrition bar	Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar

Primary Outcome Measures

Name	Time	Method
plasma total antioxidant performance, DNA damage and DNA methylation	baseline, 2 & 4 wks after supplementation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States