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The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grape powder supplementation
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy postmenopausal women aged 60 years and older Normal BMI with values between 18.4 and 24.9 kg/m2 Hand-grip strength media value of 16 kg or lower Blood pressure below 130/80 mmHg, and plasma glucose and cholesterol concentrations below 100 and 200 mg/dl. Exclusion Criteria: History of specific muscle diseases Peripheral vascular disease Intermittent claudication Central and peripheral nervous system disorders Cachexia Active diagnosis of diabetes mellitus Myocardial infarction Stroke Liver disease Dialysis Long-term steroid therapy Actively receiving treatment for cancer or severe infection (excluding short-term antibiotic therapy) Weight less than 140 pounds Anemia and blood donations in the past 30 days. Participants should not be taking dietary supplements at the time of the study

Sites / Locations

  • Nutrition Department, Ragle Facility University of California, DavisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

grape group

placebo group

Arm Description

The participant of this group will received a lyophilized grape powder

The participant of this group will received a lyophilized powder similar to the grape one

Outcomes

Primary Outcome Measures

Plasma irisin levels
The investigators will measure irisin levels in plasma

Secondary Outcome Measures

Full Information

First Posted
April 26, 2023
Last Updated
September 28, 2023
Sponsor
University of California, Davis
Collaborators
California Table Grape Commission
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1. Study Identification

Unique Protocol Identification Number
NCT05863507
Brief Title
The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women
Official Title
The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
California Table Grape Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sarcopenia, characterized by loss of muscle mass and function, is a prevalent disorder in elderly individuals or individuals with chronic diseases. Given the above, there is an ongoing intensive search for novel therapies, including dietary ones, that can attenuate the loss of muscle mass and strength in the elderly. A proposed mechanism by which skeletal muscles might mediate their protective effect against sarcopenia is by secreting myokines as irisin. Phenolic compounds presents in grape have shown to be able to induce irisin secretion in muscle from rats supplemented with a grape pomace extract. The Ian of this study is to evaluate this mechanism in humans.
Detailed Description
Scientific rationale Sarcopenia, characterized by loss of muscle mass and function, is a prevalent disorder in elderly individuals or individuals with chronic diseases. It leads to fragility and disability, worsens the prognosis of many diseases, and significantly enhances morbidity and mortality. With the increasing life expectancy and rapid growth of the aged population, sarcopenia is becoming an emerging public health issue with huge socioeconomic burden. Given the above, there is an ongoing intensive search for novel therapies, including dietary ones, that can attenuate the loss of muscle mass and strength in the elderly. Interestingly, a growing body of research indicate that nutritional factors can preserve muscle function from age- related decline. In particular, phenolic compounds, widely distributed in fruits including grapes, have shown beneficial effects in muscle health. However, the exact influence of grapes and grapes phenolic compounds mitigating sarcopenia in humans remains unexplored. A proposed mechanism by which skeletal muscles might mediate their protective effect against sarcopenia is by secreting myokines. Irisin is a myokine regulated by peroxisome proliferator- activated receptor gamma co-activator-1α (PGC-1α) and released into the bloodstream after cleavage of the Fibronectin type III domain-containing protein 5 (FNDC5). Recent studies have indicated that circulating irisin can promote skeletal muscle growth. Lower irisin concentrations have been observed in sarcopenia patients and dialyzed patients with cardiovascular disease. Furthermore, lower irisin plasma levels are associated with sarcopenia in postmenopausal women. In a recent study, it have been shown that phenolic compounds present in a grape pomace extract (GPE), rich in phenolic compounds, prevent irisin downregulation in rats fed a high-fat diet and in L6 myotube cells. In particular, we documented that consumption of the GPE activates the FNDC5/irisin pathway, increased AMPK phosphorylation in skeletal muscle and increased irisin plasma levels. These data strongly indicate that phenolic compounds enhance irisin levels in vitro and in vivo. These intriguing data allow us to hypothesize that phenolic compounds present in grapes might prevent sarcopenia in elderly humans, in part, by increasing irisin levels. Specific objectives The objective of this proposal is to evaluate whether the daily consumption of a freeze-dried table grape powder, rich in phenolic compounds, mitigates sarcopenia in postmenopausal women. The hypothesis is that daily dietary supplementation with a grape powder improves health span, mitigates sarcopenia parameters and increases irisin plasma levels in postmenopausal women. To test this hypothesis, the following aims will be pursued: To determine the efficacy of a freeze-dried table grape powder, rich in phenolic compounds, to mitigate sarcopenia parameters in postmenopausal women. To evaluate the effect of a freeze-dried table grape powder on key metabolic regulators of sarcopenia in postmenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
grape group
Arm Type
Experimental
Arm Description
The participant of this group will received a lyophilized grape powder
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
The participant of this group will received a lyophilized powder similar to the grape one
Intervention Type
Dietary Supplement
Intervention Name(s)
Grape powder supplementation
Intervention Description
The participants will be willing to consume the grape powder dissolve in water daily for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The participants will be willing to consume the placebo powder, similar to the grape powder, dissolve in water daily for 6 weeks
Primary Outcome Measure Information:
Title
Plasma irisin levels
Description
The investigators will measure irisin levels in plasma
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy postmenopausal women aged 60 years and older Normal BMI with values between 18.4 and 24.9 kg/m2 Hand-grip strength media value of 16 kg or lower Blood pressure below 130/80 mmHg, and plasma glucose and cholesterol concentrations below 100 and 200 mg/dl. Exclusion Criteria: History of specific muscle diseases Peripheral vascular disease Intermittent claudication Central and peripheral nervous system disorders Cachexia Active diagnosis of diabetes mellitus Myocardial infarction Stroke Liver disease Dialysis Long-term steroid therapy Actively receiving treatment for cancer or severe infection (excluding short-term antibiotic therapy) Weight less than 140 pounds Anemia and blood donations in the past 30 days. Participants should not be taking dietary supplements at the time of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo G Mackenzie, PhD
Phone
530-752-2140
Email
ggmackenzie@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Rodriguez Lanzi, PhD
Phone
+5492616896789
Email
mcrod@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francene G Steinberg, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Study Chair
Facility Information:
Facility Name
Nutrition Department, Ragle Facility University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianna L Mendez
Email
jlmendez@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Cecilia Rodriguez Lanzi, PhD
Phone
05492616896789
Email
mcrod@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women

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