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Effect of Whole-grape Powder on Body Composition, Fat and Bone Serum Biomarkers in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01717820
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Dietary Supplement: Freeze-dried whole-grape powder

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Whole-grape Powder on Body Composition, Fat, and Bone Serum Biomarkers in Postmenopausal Women
Study Start Date : April 2012
Primary Completion Date : August 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Freeze-dried whole-grape powder
Freeze-dried whole-grape powder (46g/day)will be provided to participants for 12 weeks.
Dietary Supplement: Freeze-dried whole-grape powder
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.


Outcome Measures

Primary Outcome Measures :
  1. Effect of freeze-dried whole-grape powder on body composition in postmenopausal women [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Effect of freeze-dried whole-grape powder on biomarkers of inflammation, adipose metabolism, and bone formation in post menopausal women. [ Time Frame: 12 weeks ]
    Freeze-dried whole-grape powder may improve body composition by increasing antioxidant capacity, resulting in decreased inflammatory eicosanoids derived from linoleic acid (ω-6), essential fatty acids (EFA) by cyclooxygenase-2 (Cox-2), and 5-lipoxygenase (5-Lox) enzymes such as prostaglandin E2 (PGE2) and leukotriene B4 (LTB4); PGE2 and LTB4 inhibit adipose tissue activity, indicated by reduction in fat using DXA, and markers of fat tissue metabolism such as serum leptin and serum adiponectin. In addition, it is hypothesized that freeze-dried whole-grape powder may reduce markers of bone resorption such as cross-linked N-teleopeptide of type I collagen (NTX) and increase bone formation markers such as bone-specific alkaline phosphatase (ALP), osteocalcin (OC), and insulin-like growth factor 1(IGF-1).

  2. Effect of freeze-dried whole-grape powder on bone resorption in postmenopausal women [ Time Frame: 12 weeks ]
    Freeze-dried whole-grape powder may reduce markers of bone resorption such as cross-linked N-teleopeptide of type I collagen (NTX) and increase bone formation markers such as bone-specific alkaline phosphatase (ALP), osteocalcin (OC), and insulin-like growth factor 1(IGF-1).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717820


Locations
United States, Texas
Institute for Women's Health, Texas Woman's University
Denton, Texas, United States, 76204-5876
Sponsors and Collaborators
Texas Woman's University
The California Table grape Commission
Investigators
Principal Investigator: Nancy M DiMarco, PhD Professor and Director, Institute for Women's Health
More Information

Additional Information:
Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT01717820     History of Changes
Other Study ID Numbers: 16850
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by Texas Woman's University:
Obesity
Postmenopausal women
Body composition
Resveratrol
Inflammatory biomarkers
Bone formation
Adipose metabolism

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents