NCT01717820

Brief Summary

The purpose of the study is to provide whole-grape powder or a placebo as a supplement to postmenopausal women for 12 weeks to determine the effects on body composition and bone formation.It is hypothesized that 12 weeks of supplementation with whole-grape powder will decrease body fat via resveratrol's positive effects on metabolism and negative effects on fat cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

September 7, 2012

Last Update Submit

October 30, 2012

Conditions

Obesity

Keywords

ObesityPostmenopausal womenBody compositionResveratrolInflammatory biomarkersBone formationAdipose metabolism

Outcome Measures

Primary Outcomes (1)

  • Effect of freeze-dried whole-grape powder on body composition in postmenopausal women

    Body composition measurements will be taken to assess the participant's percentage of fat and lean tissue. Height and weight of participants will be measured with a stadiometer and a calibrated electronic scale. In addition, waist circumference will be measured. The waist-to-hip ratio at the minimal waist and maximal hip locations will be measured with a steel measuring tape. Height (m) and weight (kg) will be used to measure the participant's body mass index. Participants will undergo a dual energy X-ray absorptiometry (DXA) scan. Total bone mineral density, percentages of fat and lean body mass and regional values of the android or gynoid regions will be measured.

    12 weeks

Secondary Outcomes (2)

  • Effect of freeze-dried whole-grape powder on biomarkers of inflammation, adipose metabolism, and bone formation in post menopausal women.

    12 weeks

  • Effect of freeze-dried whole-grape powder on bone resorption in postmenopausal women

    12 weeks

Study Arms (1)

Freeze-dried whole-grape powder

EXPERIMENTAL

Freeze-dried whole-grape powder (46g/day)will be provided to participants for 12 weeks.

Dietary Supplement: Freeze-dried whole-grape powder

Interventions

Freeze-dried whole-grape powderDIETARY_SUPPLEMENT

Participants are provided the equivalent of two servings per day of freeze-dried grape powder in a double-blind, placebo controlled, randomized design to determine the impact of the phytochemical, resveratrol, on biomarkers of adipose metabolism and bone metabolism.

Freeze-dried whole-grape powder

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postmenopausal women in first five years of menopause,
  • history of physical inactivity,
  • low intake of fruits and vegetables

You may not qualify if:

  • Not postmenopausal women,
  • men,
  • beyond five years of menopause,
  • history of physical activity,
  • high intake of fruits and vegetables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Women's Health, Texas Woman's University

Denton, Texas, 76204-5876, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy M DiMarco, PhD

    Professor and Director, Institute for Women's Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

October 31, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

US(1)