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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Tufts University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Academy of Agricultural science, Korea
SungKyunKwan University, Korea
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00963118
First received: August 20, 2009
Last updated: September 8, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • plasma total antioxidant performance, DNA damage and DNA methylation [ Time Frame: baseline, 2 & 4 wks after supplementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963118

Locations
United States, Massachusetts
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, Korea
  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:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014