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Completed

NCT Number: NCT01751750

Grape Polyphenol Kinetics in Humans

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.

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Key information

Conditions

Healthy Volunteers

Age range

Up to 59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grape

Other

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).

Primary outcomes

  1. Plasma polyphenols

    Time frame: 6 hours

    Blood will be analyzed for polyphenols and polyphenol metabolites.

  2. Urinary polyphenols

    Time frame: 6 hours

    Urine will be analyzed for polyphenols and polyphenol metabolites.

Sponsors and collaborators

Lead sponsor

Janet Novotny

Fed

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 18, 2012
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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