Overview

This trial is active, not recruiting.

Condition metabolic syndrome
Treatment plant based nutrition bar
Sponsor Tufts University
Collaborator National Academy of Agricultural science, Korea
Start date June 2009
End date July 2010
Trial size 36 participants
Trial identifier NCT00963118, FRGN52

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
Rice powder based nutrition bar
plant 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.
(Experimental)
Angelica keiskei (green leafy vegetable) based nutrition bar
plant 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.
(Experimental)
Glycine max (black soybeans) based nutrition bar
plant 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.
(Experimental)
Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar
plant 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.

Primary Outcomes

Measure
plasma total antioxidant performance, DNA damage and DNA methylation
time frame: baseline, 2 & 4 wks after supplementation

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Tufts University.