SarcopeniaNCT05863507
The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women
A study testing Grape powder supplementation in people with Sarcopenia, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Grape powder supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 14 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of specific muscle diseases
- Peripheral vascular disease
- Intermittent claudication
- Central and peripheral nervous system disorders
- Cachexia
- Active diagnosis of diabetes mellitus
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition Department, Ragle Facility University of California, Davis
Davis, California, 95616
About this study
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Grape powder supplementation, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape powder supplementationDietary supplement
The participants will be willing to consume the grape powder dissolve in water daily for 6 weeks
PlaceboDietary supplement
The participants will be willing to consume the placebo powder, similar to the grape powder, dissolve in water daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| grape group | Experimental | The participant of this group will received a lyophilized grape powder Receives: Dietary Supplement: Grape powder supplementation |
| placebo group | Placebo comparator | The participant of this group will received a lyophilized powder similar to the grape one Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma irisin levels
The investigators will measure irisin levels in plasma
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Apr 2023
- Primary completion14 Jul 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Table Grape Commission
- Responsible party
- Sponsor
- Investigators
- Francene G Steinberg, PhD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863507
- Sponsor's protocol ID
- 1867416
- Status last verified
- Nov 2024
- First submitted
- 26 Apr 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Daily Grapes Intake on Sarcopenia in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05863507
- Acronym / sponsor ID
- 1867416
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Table Grape Commission
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grape group | Experimental | Dietary Supplement: Grape powder supplementationThe participant of this group will received a lyophilized grape powder |
| placebo group | Placebo comparator | Dietary Supplement: PlaceboThe participant of this group will received a lyophilized powder similar to the grape one |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- History of specific muscle diseases
- Peripheral vascular disease
- Intermittent claudication
- Central and peripheral nervous system disorders
- Cachexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape powder supplementationThe participants will be willing to consume the grape powder dissolve in water daily for 6 weeks | Dietary supplement | grape group |
| PlaceboThe participants will be willing to consume the placebo powder, similar to the grape powder, dissolve in water daily for 6 weeks | Dietary supplement | placebo group |
Primary outcome
Plasma irisin levels
Time frame: 6 weeks
The investigators will measure irisin levels in plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francene G Steinberg, PhD study chair
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape powder supplementation in people with Sarcopenia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma irisin levels (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.