Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

NCT00963118 | Completed

• 1 other identifier: FRGN52
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Angelica keiskei; Glycine max; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• plasma total antioxidant performance, DNA damage and DNA methylation

  baseline, 2 & 4 wks after supplementation

Secondary Outcomes (1)

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

  Baseline, 2 & 4 wks after supplementation

Study Arms (4)

placebo

PLACEBO COMPARATOR

Rice powder based nutrition bar

Dietary Supplement: plant based nutrition bar

Angelica keiskei

EXPERIMENTAL

Angelica keiskei (green leafy vegetable) based nutrition bar

Dietary Supplement: plant based nutrition bar

Glycine max

EXPERIMENTAL

Glycine max (black soybeans) based nutrition bar

Dietary Supplement: plant based nutrition bar

Angelica keiskei + Glycine max

EXPERIMENTAL

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

Dietary Supplement: plant based nutrition bar

Interventions

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.

Angelica keiskei; Angelica keiskei + Glycine max; Glycine max; placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead
• National Academy of Agricultural science, Korea: collaborator
• Sungkyunkwan University: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)