Viewing Study NCT05863507



Ignite Creation Date: 2024-05-06 @ 7:00 PM
Last Modification Date: 2024-10-26 @ 2:58 PM
Study NCT ID: NCT05863507
Status: RECRUITING
Last Update Posted: 2023-10-02
First Post: 2023-04-26

Brief Title: The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women
Sponsor: University of California Davis
Organization: University of California Davis

Study Overview

Official Title: The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women
Status: RECRUITING
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 FNDC5irisin 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None