Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability (Biogreen)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome |
Dietary Supplement: plant based nutrition bar |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability |
- plasma total antioxidant performance, DNA damage and DNA methylation [ Time Frame: baseline, 2 & 4 wks after supplementation ] [ Designated as safety issue: No ]
- hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid) [ Time Frame: Baseline, 2 & 4 wks after supplementation ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo
Rice powder based nutrition bar
|
Dietary Supplement: 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
Angelica keiskei (green leafy vegetable) based nutrition bar
|
Dietary Supplement: 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
Glycine max (black soybeans) based nutrition bar
|
Dietary Supplement: 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 + Glycine max
Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar
|
Dietary Supplement: 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.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: healthy control group (n=20)
- Age: over 50 years old
- Female subjects must be post-menopausal
- BMI: 18.5 - 30, waist/hip ratio < 0.9 for men, < 0.85 for women
- TG<150 mg/dL (1.7 mmol/L) and no medication for TG
- Total cholesterol < 200 mg /dL (5.18 mmol/L) and no medication for cholesterol
- Blood pressure: SBP < 130 mmHg and DBP < 85 mmHg and no hypertensive medication
- Plasma glucose: fasting blood glucose < 100 mg/dL (5.6 mmol/L) and no diabetes medication
Inclusion Criteria: Metabolic syndrome (n=40)
- Age: over 50 years old
- BMI: > 30 or waist/hip ratio > 0.9 for men, > 0.85 for women
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:
- Study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption.
- 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.
- Exogenous hormone users will be excluded from the study.
- 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.
Contacts and Locations| United States, Massachusetts | |
| Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University | |
| Boston, Massachusetts, United States, 02111 | |
More Information
No publications provided
| Responsible Party: | Kyung-Jin Yeum, Tufts university |
| ClinicalTrials.gov Identifier: | NCT00963118 History of Changes |
| Other Study ID Numbers: | FRGN52 |
| Study First Received: | August 20, 2009 |
| Last Updated: | September 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tufts University:
|
Angelica keiskei Glycine max metabolic syndrome |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Genomic Instability Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Pathologic Processes |
Glycine Glycine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013