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NCT Number: NCT00963118

Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plant based nutrition bar

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.

Primary outcomes

  1. plasma total antioxidant performance, DNA damage and DNA methylation

    Time frame: baseline, 2 & 4 wks after supplementation

Secondary outcomes

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

    Time frame: Baseline, 2 & 4 wks after supplementation

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Academy of Agricultural science, Korea
  • Sungkyunkwan University

Registry information

Acronym: Biogreen

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2009
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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