Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Metabolic Syndrome Clinical Trial

— Biogreen  

Official title:

Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963118
• Other study ID #: FRGN52
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: April 24, 2017
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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.

Locations

Country	Name	City	State
United States	Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	National Academy of Agricultural science, Korea, Sungkyunkwan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma total antioxidant performance, DNA damage and DNA methylation		baseline, 2 & 4 wks after supplementation
Secondary	hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)		Baseline, 2 & 4 wks after supplementation