Grape Polyphenol Kinetics in Humans

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Grape

• Registration Number: NCT01751750
• Lead Sponsor: Janet Novotny

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Grape	Grape	-

Primary Outcome Measures

Name	Time	Method
Plasma polyphenols	6 hours	Blood will be analyzed for polyphenols and polyphenol metabolites.
Urinary polyphenols	6 hours	Urine will be analyzed for polyphenols and polyphenol metabolites.

Trial Locations

Locations (1)

USDA Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States