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Grape Polyphenol Kinetics in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janet Novotny, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01751750
First received: December 10, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
The Focus of the Study is to Investigate the Plasma and Urinary Metabolic Profile of Grape Juice, Resveratrol, and Grape Seed Polyphenol Extract.
 Other: Grape

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Plasma polyphenols [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Blood will be analyzed for polyphenols and polyphenol metabolites.

  • Urinary polyphenols [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Urine will be analyzed for polyphenols and polyphenol metabolites.


Enrollment: 16
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Grape Other: Grape
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).

  Eligibility

Ages Eligible for Study:   up to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751750

Locations
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
Janet Novotny
Investigators
Principal Investigator: Janet Novotny, Ph.D. USDA Beltsville Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Janet Novotny, Principal Investigator, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01751750     History of Changes
Other Study ID Numbers: HS38
Study First Received: December 10, 2012
Last Updated: December 13, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 19, 2013