Status:
COMPLETED
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Academy of Agricultural science, Korea
Sungkyunkwan University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
50+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00963118
Start Date
June 1 2009
End Date
December 1 2010
Last Update
April 25 2017
Active Locations (1)
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1
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111