Grape Polyphenol Kinetics in Humans

Janet Novotny

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: Grape

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01751750

HS38

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

Under 59 years old

Volunteers

Accepts Healthy Volunteers

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