NCT01751750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

December 10, 2012

Last Update Submit

May 23, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Plasma polyphenols

    Blood will be analyzed for polyphenols and polyphenol metabolites.

    6 hours

  • Urinary polyphenols

    Urine will be analyzed for polyphenols and polyphenol metabolites.

    6 hours

Study Arms (1)

Grape

OTHER
Other: Grape

Interventions

GrapeOTHER

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).

Grape

Eligibility Criteria

AgeUp to 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

  • Novotny JA, Chen TY, Terekhov AI, Gebauer SK, Baer DJ, Ho L, Pasinetti GM, Ferruzzi MG. The effect of obesity and repeated exposure on pharmacokinetic response to grape polyphenols in humans. Mol Nutr Food Res. 2017 Nov;61(11):10.1002/mnfr.201700043. doi: 10.1002/mnfr.201700043. Epub 2017 Aug 29.

    PMID: 28654207DERIVED

MeSH Terms

Interventions

whole grape extract

Study Officials

  • Janet Novotny, Ph.D.

    USDA Beltsville Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 18, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)