Grape Polyphenol Kinetics in Humans

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751750
• Other study ID #: HS38
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: May 23, 2017
• Start date: September 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2017
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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).

Locations

Country	Name	City	State
United States	USDA Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Janet Novotny

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma polyphenols	Blood will be analyzed for polyphenols and polyphenol metabolites.	6 hours
Primary	Urinary polyphenols	Urine will be analyzed for polyphenols and polyphenol metabolites.	6 hours