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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: plant based nutrition bar

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plasma total antioxidant performance, DNA damage and DNA methylation	baseline, 2 & 4 wks after supplementation

Secondary Outcome Measures

Outcome Measure	Time Frame
hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)	Baseline, 2 & 4 wks after supplementation

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Sungkyunkwan University; National Academy of Agricultural science, Korea

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: metabolic syndrome; Angelica keiskei; Glycine max
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Genomic Instability
• Other Study ID Numbers: FRGN52