Grape Polyphenol Kinetics in Humans

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01751750

Run by

Janet Novotny

People needed

16

Starts

2011-09-01

Expected to finish

2011-09-01

Last updated by the study team

2017-05-25

Who can join

Age: any, up to 59. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• USDA Beltsville Human Nutrition Research Center — Beltsville, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.