The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women

NCT05863507 | Completed

• 1 other identifier: 1867416
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Plasma irisin levels

  The investigators will measure irisin levels in plasma

  6 weeks

Study Arms (2)

grape group

EXPERIMENTAL

The participant of this group will received a lyophilized grape powder

Dietary Supplement: Grape powder supplementation

placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Grape powder supplementation DIETARY_SUPPLEMENT

The participants will be willing to consume the grape powder dissolve in water daily for 6 weeks

grape group

Placebo DIETARY_SUPPLEMENT

The participants will be willing to consume the placebo powder, similar to the grape powder, dissolve in water daily for 6 weeks

placebo group

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• California Table Grape Commission: collaborator

Study Sites (1)

Nutrition Department, Ragle Facility University of California, Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Francene G Steinberg, PhD

  University of California, Davis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 18, 2023
• Study Start: April 1, 2023
• Primary Completion: July 14, 2024
• Study Completion: July 14, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)