Biogreen: Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT00963118

Collaborator

National Academy of Agricultural science, Korea (Other), Sungkyunkwan University (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: plant based nutrition bar	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

plasma total antioxidant performance, DNA damage and DNA methylation [baseline, 2 & 4 wks after supplementation]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

Tufts University
National Academy of Agricultural science, Korea
Sungkyunkwan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00963118

Other Study ID Numbers:

FRGN52

First Posted:

Aug 21, 2009

Last Update Posted:

Apr 25, 2017

Last Verified:

Apr 1, 2017

Keywords provided by , ,

Angelica keiskei

Glycine max

metabolic syndrome

Additional relevant MeSH terms:

Metabolic Syndrome

Genomic Instability

Study Results

No Results Posted as of Apr 25, 2017