Grape Polyphenol Kinetics in Humans

Study Overview
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Brief Summary
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The objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and grape seed polyphenol extract result in a similar plasma and urinary metabolic profile in adults with tendencies toward metabolic syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol extract.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Grape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: Age <60 years at beginning of study Fasting glucose > 126 mg/dl Blood pressure > 160/100 Fasting total blood cholesterol > 280 mg/dl Fasting triglycerides > 300 mg/dl Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes Presence of type 2 diabetes requiring the use of oral antidiabetic agents or insulin History of bariatric or certain other surgeries related to weight control Smokers or other tobacco users (during 6 months prior to the start of the study) Consumption of more than 3 servings of tea, wine, or grape juice per day Use of supplements containing grape extracts or products Use of antibiotics during the intervention or for 3 weeks prior to the intervention period History of eating disorders, dietary patterns, or supplement use which will interfere with the goal of the intervention Volunteers who have lost 10% of body weight within the last 4 months Volunteers who are unable or unwilling to give informed consent or communicate with study staff Volunteers who self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion) Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Ages Eligible for Study
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Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Grape<br> | Other: Grape<br>* 16 oz. of Concord grape juice (8 oz. consumed 2 times per day; total dose of approximately 1.2 g phenolic compounds per day), 250 mg resveratrol provided as a capsule (commercially available supplement; 125 mg consumed 2 times per day), and 1 g grape seed polyphenol extract provided as a capsule (commercially available supplement; 0.5 g consumed 2 times per day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma polyphenols | Blood will be analyzed for polyphenols and polyphenol metabolites. | 6 hours | 
| Urinary polyphenols | Urine will be analyzed for polyphenols and polyphenol metabolites. | 6 hours |