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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
plant based nutrition bar
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Angelica keiskei, Glycine max, metabolic syndrome

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo

Angelica keiskei

Glycine max

Angelica keiskei + Glycine max

Arm Description

Rice powder based nutrition bar

Angelica keiskei (green leafy vegetable) based nutrition bar

Glycine max (black soybeans) based nutrition bar

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

Outcomes

Primary Outcome Measures

plasma total antioxidant performance, DNA damage and DNA methylation

Secondary Outcome Measures

hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)

Full Information

First Posted
August 20, 2009
Last Updated
April 24, 2017
Sponsor
Tufts University
Collaborators
National Academy of Agricultural science, Korea, Sungkyunkwan University
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1. Study Identification

Unique Protocol Identification Number
NCT00963118
Brief Title
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Acronym
Biogreen
Official Title
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tufts University
Collaborators
National Academy of Agricultural science, Korea, Sungkyunkwan University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Angelica keiskei, Glycine max, metabolic syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Rice powder based nutrition bar
Arm Title
Angelica keiskei
Arm Type
Experimental
Arm Description
Angelica keiskei (green leafy vegetable) based nutrition bar
Arm Title
Glycine max
Arm Type
Experimental
Arm Description
Glycine max (black soybeans) based nutrition bar
Arm Title
Angelica keiskei + Glycine max
Arm Type
Experimental
Arm Description
Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar
Intervention Type
Dietary Supplement
Intervention Name(s)
plant based nutrition bar
Intervention Description
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.
Primary Outcome Measure Information:
Title
plasma total antioxidant performance, DNA damage and DNA methylation
Time Frame
baseline, 2 & 4 wks after supplementation
Secondary Outcome Measure Information:
Title
hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)
Time Frame
Baseline, 2 & 4 wks after supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

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