Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

NCT ID: NCT00963118

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-12-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

placebo

Rice powder based nutrition bar

Group Type: PLACEBO_COMPARATOR

plant based nutrition bar

Intervention Type: DIETARY_SUPPLEMENT

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.

Angelica keiskei

Angelica keiskei (green leafy vegetable) based nutrition bar

Group Type: EXPERIMENTAL

plant based nutrition bar

Intervention Type: DIETARY_SUPPLEMENT

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.

Glycine max

Glycine max (black soybeans) based nutrition bar

Group Type: EXPERIMENTAL

plant based nutrition bar

Intervention Type: DIETARY_SUPPLEMENT

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.

Angelica keiskei + Glycine max

Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar

Group Type: EXPERIMENTAL

plant based nutrition bar

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Academy of Agricultural science, Korea

UNKNOWN

Sponsor Role: collaborator

Sungkyunkwan University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Tufts university

Locations

Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

FRGN52

Identifier Type: -

Identifier Source: org_study_id