The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Grape powder supplementation; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerardo G Mackenzie, PhD; Phone Number: 530-752-2140; Email: ggmackenzie@ucdavis.edu
• Study Contact Backup: Name: Cecilia Rodriguez Lanzi, PhD; Phone Number: +5492616896789; Email: mcrod@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • Nutrition Department, Ragle Facility University of California, Davis
      • Contact: Julianna L Mendez; Email: jlmendez@ucdavis.edu
      • Contact: Cecilia Rodriguez Lanzi, PhD; Phone Number: 05492616896789; Email: mcrod@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: grape group; The participant of this group will received a lyophilized grape powder	Dietary supplement: Grape powder supplementation; The participants will be willing to consume the grape powder dissolve in water daily for 6 weeks
Placebo Comparator: placebo group; The participant of this group will received a lyophilized powder similar to the grape one	Dietary supplement: Placebo; The participants will be willing to consume the placebo powder, similar to the grape powder, dissolve in water daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma irisin levels	The investigators will measure irisin levels in plasma	6 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: California Table Grape Commission
• Investigators: Study Chair: Francene G Steinberg, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 1867416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No