HealthyNCT07208916
Evaluation of the Potential of Grape Consumption to Improve Muscle Strength and Cognitive Function
A study testing Grape Powder in people with Healthy, run by Western New England University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if eating grapes can improve muscle strength and thinking in generally healthy women over 65. The main questions it aims to answer are: Does eating grapes improve muscle strength in women over 65? Does eating grapes improve cognition in women over 65? Participants will be… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Grape Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy female (confirmed by medical history)
- Aged 65 or older;
- Able to walk household distances without assistance from another person
- Non-smoker;
- Dominant hand grip strength at or below normal value for age and gender;
- Had not consumed recreational drugs for one week prior;
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- Agreed not to participate in any clinical or patch test studies at Day 1 through study completion;
- Completed a medical intake;
- Read, understood, and signed an informed consent.
Who cannot join
- Using nasally inhaled/systemic/topical corticosteroids within 4 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- Using certain antifungal drugs, antihistamines (including diphenhydramine, or Benadryl), antibiotics 4 (including "sulfa" drugs, quinolones and tetracyclines), oral diabetes drugs, sulfonylureas, diuretics, and tricyclic antidepressants. Some herbal supplements such as St. John's Wort would make a person ineligible;
- Not willing to refrain from using acetaminophen (occasional use permitted, except within 48 hours of a study visit) or systemic/topical anti-inflammatory analgesics such as aspirin, Aleve, Motrin, Advil, Orudis, or Nuprin for 72 hours prior to and during study visits;
- Any of the following in the 4 weeks prior to start of study:
- Major surgery for any indication
- On cytotoxic chemotherapy for any indication (including methotrexate for arthritis)
Show all 29Show fewer
- Hormonal therapy for cancer prevention (including tamoxifen). Note: treatment with finasteride/dutasteride for BPH does not render a participant ineligible
- Using medication which, in the opinion of the Investigator, would interfere with the study results (e.g., anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications; blood thinners);
- Known sensitivity or allergy to grape powder;
- Nut allergies;
- Had received treatment for any type of internal cancer within 5 years prior to study entry;
- Had a history of or currently being treated for:
- Hepatitis;
- Diabetes (including insulin injections);
- Solid organ or bone marrow transplant
- Keloid formation
- Chronic renal or hepatic disorder
- Significant bleeding disorder
- Progressive neurodegenerative condition
- Swallowing disorder
- OTHER
- Any condition that might have compromised study results;
- Uncontrolled concurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that limited compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion precluded study participation.
- Currently participating in any clinical testing; c. Received any investigational drug(s) within 28 days from Day 1.
- Participants must also follow the following Subject Responsibilities:
- Participants are not to consume the following foods during the study: Artichokes, figs, green tea, almonds, red fruits and vegetables, turmeric, olive oil, berries (blueberries, blackberries, grapes, raspberries, strawberries, goji berries, etc.), cocoa, dark chocolate, pomegranate, red wine
- Participants are to limit the following foods during the study:
- Coffee/Tea - 1X per day, beans/legumes - 2X per week, Soy foods (tofu, soy milk, miso, tempeh) 2X per week
- Participants are not to consume the following supplements during the study: Multivitamin, Alpha lipoic acid, B vitamins, Coenzyme Q10, Elderberry, Ellagic acid, Fish oil, Flaxseed or flaxseed oil, Grapeseed extract, Green tea, Lycopene 6, Niacinamide, Quercetin, Resveratrol, Selenium, Turmeric, Vitamin C, E, K
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael V Salemi contact
United States1 site, 1 recruiting
- Recruiting
Western New England University
Springfield, Massachusetts, 01119
Brittany C Adams, 413-782-1443, brittany.adams@wne.edu
Michael Salemi, michael.salemi@wne.edu
About this study
Official title: Evaluation of Grape Consumption to Improve Muscle Strength and Cognitive Function
The goal of this clinical trial is to learn if eating grapes can improve muscle strength and thinking in generally healthy women over 65. The main questions it aims to answer are:
Does eating grapes improve muscle strength in women over 65? Does eating grapes improve cognition in women over 65?
Participants will be asked to take part in 4 sessions on campus. Each session will include:
Functional muscle strength testing Cognitive testing Blood draws
Read the detailed description
The goal of this project is to perform a translational study to evaluate the potential of grape consumption to improve muscle and cognitive function with female human volunteers. The study will examine the impact of grape consumption on the functional strength and cognition of females over the age of 65. We will recruit 35 women who are in good overall health. On Day 1, consented participants will undergo baseline screening and assessments and will receive education on dietary restrictions for the following two weeks. After the two-week run-in diet period, on Day 14 participants will complete functional strength and cognitive testing, provide blood samples, and receive pouches of grape powder to be ingested daily. During the grape consumption phase of the trial, participants will ingest two 36 g pouches of grape powder daily for 30 days - equivalent to three servings of fresh grapes per day. Additional blood work, strength and cognitive testing will be performed on Day 28 and again on Day 42. Results will help to inform future studies on the effectiveness of regular grape intake on functional muscle strength and cognition in women over the age of 65, along with serum markers that are indicative of underlying mechanisms of action.
- Conditions
- Healthy
- Being tested
- Grape Powder
- Keywords
- grapes, diet, muscle strength, cognition, sarcopenia, serum biomarkers, women
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape PowderDietary supplement
All participants will consume two 36g packets of grape powder (mixed with water) daily for two, 2-week periods during the study. Participants will mix pre-measured grape powder with water and drink twice a day (once in the morning and in the afternoon/evening) for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grape Powder Arm | Experimental | All subjects will consume two 36g packets of grape powder (mixed with water) daily for two, 2-week periods during the study. Receives: Dietary Supplement: Grape Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker - Myostatin
Through serum analysis, myostatin will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment to the end of treatment at 4 weeks
Biomarker - IL-6
Through serum analysis, Interleukin-6 (IL-6) will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through treatment at week 4
Biomarker - GDF-15
Through serum analysis, Growth Differentiation Factor 15 (GDF-15) will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment to the end of treatment at 4 weeks
BIomarker - BDNF
Through serum analysis, Brain-derived neurotrophic factor (BDNF) will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through end of treatment at 4 weeks
Biomarker - Cystatin C
Through serum analysis, biomarker Cystatin C will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through the end of treatment at 4 weeks
Biomarker - TNF-α
Through serum analysis, biomarker Tumor necrosis factor-alpha will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through the end of treatment at 4 weeks
Biomarker - CRP
Through serum analysis, biomarker C-reactive protein (CRP) will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through the end of treatment at 4 weeks
Biomarker - CCL-2/MCP-1
Through serum analysis, biomarker C-C motif chemokine ligand 2 / Monocyte chemoattractant protein 1 will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through the end of treatment at 4 weeks
Biomarker - CAF
Through serum analysis, biomarker C-terminal fragment of agrin (CAF) will be measured in units of pg/mL at three points throughout the study.
Measured: From start of enrollment through the end of treatment at 4 weeks
Biomarker - Malondialdehyde
Through serum analysis, biomarker malondialdehyde will be measured in units of µM at three points throughout the study.
Measured: From start of enrollment through the end of treatment at 4 weeks
Secondary outcomes (7)
Functional Cognition
Montreal Cognitive Assessment (MoCA) - a brief cognitive screening tool that effectively detects mild cognitive impairment, offering greater sensitivity than other instruments like the MMSE. It assesses multiple cognitive domains and is validated for use in older populations.
Measured: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Bilateral Grip Strength
Bilateral Grip Strength -Hydraulic Hand Dynamometer - a reliable indicator of overall muscular strength and has been correlated with functional status and health outcomes in older adults.
Measured: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Bilateral Pinch Strength
Bilateral Pinch Strength -Hydraulic Pinch Gauge - provide insight into fine motor function and hand dexterity, which are crucial for daily activities.
Measured: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Standing Balance
Standing Balance - Timed Up and Go (TUG) Test - a quick and effective measure of mobility and balance, predicting fall risk in older populations.
Measured: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Overall Physical Performance
Overall Physical Performance - Short Physical Performance Battery (SPPB) -evaluates lower extremity function through balance, gait speed, and chair stand tests. It is a validated tool for assessing physical performance and predicting disability and mortality in older adults.
Measured: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Self-Reported Instrumental Activities of Daily Living
Self-Reported Instrumental Activities of Daily Living - Lawton-Brody IADL Scale - assesses an individual's ability to perform complex daily tasks, providing insight into functional independence.
Measured: From start of enrollment to the end of treatment at 4 weeks
Body Composition Total Score
A body composition total score is an indicator of an individual's overall health by quantifying their body's components (fat, muscle, bone, and water) and providing a numerical rating, often out of 100, that serves as a health risk indicator. A body composition analysis machine will be used for this calculation.
Measured: From start of enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start9 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western New England University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittany Adams, Western New England University
- Investigators
- Brittany C Adams, Principal investigator, Western New England University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208916
- Sponsor's protocol ID
- WNEIRB001
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Dautzenberg G, Lijmer J, Beekman A. Diagnostic accuracy of the Montreal Cognitive Assessment (MoCA) for cognitive screening in old age psychiatry: Determining cutoff scores in clinical practice. Avoiding spectrum bias caused by healthy controls. Int J Geriatr Psychiatry. 2020 Mar;35(3):261-269. doi: 10.1002/gps.5227. Epub 2019 Dec 27.
PubMed 31650623Graf C. The Lawton Instrumental Activities of Daily Living (IADL) Scale. Medsurg Nurs. 2009 Sep-Oct;18(5):315-6. No abstract available.
PubMed 19927971Phu S, Kirk B, Bani Hassan E, Vogrin S, Zanker J, Bernardo S, Duque G. The diagnostic value of the Short Physical Performance Battery for sarcopenia. BMC Geriatr. 2020 Jul 13;20(1):242. doi: 10.1186/s12877-020-01642-4.
PubMed 32660438Leger, H., Tittle, R., Dowdell, S., & Thompson, C., (2022). Comparison of the Validity of the Timed Up and Go Test (TUG) and Activities-specific Balance Confidence Questionnaire (ABC) to the 'Gold Standard' Berg Balance Scale (BBS) in Assessing Fall Risk in the Elderly Population. J Rehab Pract Res, 3(2):133. https://doi.org/10.33790/jrpr1100133
MacDermid JC, Evenhuis W, Louzon M. Inter-instrument reliability of pinch strength scores. J Hand Ther. 2001 Jan-Mar;14(1):36-42. doi: 10.1016/s0894-1130(01)80023-5.
PubMed 11243558Reza MM, Subramaniyam N, Sim CM, Ge X, Sathiakumar D, McFarlane C, Sharma M, Kambadur R. Irisin is a pro-myogenic factor that induces skeletal muscle hypertrophy and rescues denervation-induced atrophy. Nat Commun. 2017 Oct 24;8(1):1104. doi: 10.1038/s41467-017-01131-0.
PubMed 29062100Nara H, Watanabe R. Anti-Inflammatory Effect of Muscle-Derived Interleukin-6 and Its Involvement in Lipid Metabolism. Int J Mol Sci. 2021 Sep 13;22(18):9889. doi: 10.3390/ijms22189889.
PubMed 34576053Kamper RS, Nygaard H, Praeger-Jahnsen L, Ekmann A, Ditlev SB, Schultz M, Hansen SK, Hansen P, Pressel E, Suetta C. GDF-15 is associated with sarcopenia and frailty in acutely admitted older medical patients. J Cachexia Sarcopenia Muscle. 2024 Aug;15(4):1549-1557. doi: 10.1002/jcsm.13513. Epub 2024 Jun 18.
PubMed 38890783Bagheri R, Rashidlamir A, Motevalli MS, Elliott BT, Mehrabani J, Wong A. Effects of upper-body, lower-body, or combined resistance training on the ratio of follistatin and myostatin in middle-aged men. Eur J Appl Physiol. 2019 Sep;119(9):1921-1931. doi: 10.1007/s00421-019-04180-z. Epub 2019 Jun 25.
PubMed 31240397Tabara Y, Kohara K, Okada Y, Ohyagi Y, Igase M. Creatinine-to-cystatin C ratio as a marker of skeletal muscle mass in older adults: J-SHIPP study. Clin Nutr. 2020 Jun;39(6):1857-1862. doi: 10.1016/j.clnu.2019.07.027. Epub 2019 Aug 6.
PubMed 31431305Renteria I, Garcia-Suarez PC, Fry AC, Moncada-Jimenez J, Machado-Parra JP, Antunes BM, Jimenez-Maldonado A. The Molecular Effects of BDNF Synthesis on Skeletal Muscle: A Mini-Review. Front Physiol. 2022 Jul 6;13:934714. doi: 10.3389/fphys.2022.934714. eCollection 2022.
PubMed 35874524Ladang A, Beaudart C, Reginster JY, Al-Daghri N, Bruyere O, Burlet N, Cesari M, Cherubini A, da Silva MC, Cooper C, Cruz-Jentoft AJ, Landi F, Laslop A, Maggi S, Mobasheri A, Ormarsdottir S, Radermecker R, Visser M, Yerro MCP, Rizzoli R, Cavalier E. Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Academique de Recherche et d'Experimentation en Sante (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging. Calcif Tissue Int. 2023 Feb;112(2):197-217. doi: 10.1007/s00223-022-01054-z. Epub 2023 Jan 12.
PubMed 36633611Rosner B. Fundamentals of Biostatistics. 7th ed. Boston, MA: Brooks/Cole; 2011.
von Haehling S, Morley JE, Anker SD. An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):129-133. doi: 10.1007/s13539-010-0014-2. Epub 2010 Dec 17.
PubMed 21475695Maher, P. Grapes and the Brain. In Grapes and Health; Pezzuto, J.M., Ed.; Springer International Publishing: Cham, Switzerland, 2016; pp. 139-161.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Grape Consumption to Improve Muscle Strength and Cognitive Function
- ClinicalTrials.gov ID
- NCT07208916
- Acronym / sponsor ID
- WNEIRB001
- Conditions
- Healthy
- Keywords
- grapes, diet, muscle strength, cognition, sarcopenia, serum biomarkers, women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Western New England UniversityUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
The goal of this clinical trial is to learn if eating grapes can improve muscle strength and thinking in generally healthy women over 65. The main questions it aims to answer are:
Does eating grapes improve muscle strength in women over 65? Does eating grapes improve cognition in women over 65?
Participants will be asked to take part in 4 sessions on campus. Each session will include:
Functional muscle strength testing Cognitive testing Blood draws
Detailed description
The goal of this project is to perform a translational study to evaluate the potential of grape consumption to improve muscle and cognitive function with female human volunteers. The study will examine the impact of grape consumption on the functional strength and cognition of females over the age of 65. We will recruit 35 women who are in good overall health. On Day 1, consented participants will undergo baseline screening and assessments and will receive education on dietary restrictions for the following two weeks. After the two-week run-in diet period, on Day 14 participants will complete functional strength and cognitive testing, provide blood samples, and receive pouches of grape powder to be ingested daily. During the grape consumption phase of the trial, participants will ingest two 36 g pouches of grape powder daily for 30 days - equivalent to three servings of fresh grapes per day. Additional blood work, strength and cognitive testing will be performed on Day 28 and again on Day 42. Results will help to inform future studies on the effectiveness of regular grape intake on functional muscle strength and cognition in women over the age of 65, along with serum markers that are indicative of underlying mechanisms of action.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grape Powder Arm | Experimental | Dietary Supplement: Grape PowderAll subjects will consume two 36g packets of grape powder (mixed with water) daily for two, 2-week periods during the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Healthy female (confirmed by medical history)
- Aged 65 or older;
- Able to walk household distances without assistance from another person
- Non-smoker;
- Dominant hand grip strength at or below normal value for age and gender;
Key exclusion criteria (29 listed)
- Using nasally inhaled/systemic/topical corticosteroids within 4 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- Using certain antifungal drugs, antihistamines (including diphenhydramine, or Benadryl), antibiotics 4 (including "sulfa" drugs, quinolones and tetracyclines), oral diabetes drugs, sulfonylureas, diuretics, and tricyclic antidepressants. Some herbal supplements such as St. John's Wort would make a person ineligible;
- Not willing to refrain from using acetaminophen (occasional use permitted, except within 48 hours of a study visit) or systemic/topical anti-inflammatory analgesics such as aspirin, Aleve, Motrin, Advil, Orudis, or Nuprin for 72 hours prior to and during study visits;
- Any of the following in the 4 weeks prior to start of study:
- Known sensitivity or allergy to grape powder;
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 PowderAll participants will consume two 36g packets of grape powder (mixed with water) daily for two, 2-week periods during the study. Participants will mix pre-measured grape powder with water and drink twice a day (once in the morning and in the afternoon/evening) for two weeks. | Dietary supplement | Grape Powder Arm |
Primary outcome
Biomarker - Myostatin
Time frame: From start of enrollment to the end of treatment at 4 weeks
Through serum analysis, myostatin will be measured in units of pg/mL at three points throughout the study.
Biomarker - IL-6
Time frame: From start of enrollment through treatment at week 4
Through serum analysis, Interleukin-6 (IL-6) will be measured in units of pg/mL at three points throughout the study.
Biomarker - GDF-15
Time frame: From start of enrollment to the end of treatment at 4 weeks
Through serum analysis, Growth Differentiation Factor 15 (GDF-15) will be measured in units of pg/mL at three points throughout the study.
BIomarker - BDNF
Time frame: From start of enrollment through end of treatment at 4 weeks
Through serum analysis, Brain-derived neurotrophic factor (BDNF) will be measured in units of pg/mL at three points throughout the study.
Biomarker - Cystatin C
Time frame: From start of enrollment through the end of treatment at 4 weeks
Through serum analysis, biomarker Cystatin C will be measured in units of pg/mL at three points throughout the study.
Biomarker - TNF-α
Time frame: From start of enrollment through the end of treatment at 4 weeks
Through serum analysis, biomarker Tumor necrosis factor-alpha will be measured in units of pg/mL at three points throughout the study.
Biomarker - CRP
Time frame: From start of enrollment through the end of treatment at 4 weeks
Through serum analysis, biomarker C-reactive protein (CRP) will be measured in units of pg/mL at three points throughout the study.
Biomarker - CCL-2/MCP-1
Time frame: From start of enrollment through the end of treatment at 4 weeks
Through serum analysis, biomarker C-C motif chemokine ligand 2 / Monocyte chemoattractant protein 1 will be measured in units of pg/mL at three points throughout the study.
Biomarker - CAF
Time frame: From start of enrollment through the end of treatment at 4 weeks
Through serum analysis, biomarker C-terminal fragment of agrin (CAF) will be measured in units of pg/mL at three points throughout the study.
Biomarker - Malondialdehyde
Time frame: From start of enrollment through the end of treatment at 4 weeks
Through serum analysis, biomarker malondialdehyde will be measured in units of µM at three points throughout the study.
7 secondary outcomes
Functional Cognition
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Bilateral Grip Strength
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Bilateral Pinch Strength
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Standing Balance
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Overall Physical Performance
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Self-Reported Instrumental Activities of Daily Living
Time frame: From start of enrollment to the end of treatment at 4 weeks
Body Composition Total Score
Time frame: From start of enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 31650623Dautzenberg G, Lijmer J, Beekman A. Diagnostic accuracy of the Montreal Cognitive Assessment (MoCA) for cognitive screening in old age psychiatry: Determining cutoff scores in clinical practice. Avoiding spectrum bias caused by healthy controls. Int J Geriatr Psychiatry. 2020 Mar;35(3):261-269. doi: 10.1002/gps.5227. Epub 2019 Dec 27.
- Background: PubMed 19927971Graf C. The Lawton Instrumental Activities of Daily Living (IADL) Scale. Medsurg Nurs. 2009 Sep-Oct;18(5):315-6. No abstract available.
- Background: PubMed 32660438Phu S, Kirk B, Bani Hassan E, Vogrin S, Zanker J, Bernardo S, Duque G. The diagnostic value of the Short Physical Performance Battery for sarcopenia. BMC Geriatr. 2020 Jul 13;20(1):242. doi: 10.1186/s12877-020-01642-4.
- BackgroundLeger, H., Tittle, R., Dowdell, S., & Thompson, C., (2022). Comparison of the Validity of the Timed Up and Go Test (TUG) and Activities-specific Balance Confidence Questionnaire (ABC) to the 'Gold Standard' Berg Balance Scale (BBS) in Assessing Fall Risk in the Elderly Population. J Rehab Pract Res, 3(2):133. https://doi.org/10.33790/jrpr1100133
- Background: PubMed 11243558MacDermid JC, Evenhuis W, Louzon M. Inter-instrument reliability of pinch strength scores. J Hand Ther. 2001 Jan-Mar;14(1):36-42. doi: 10.1016/s0894-1130(01)80023-5.
- Background: PubMed 29062100Reza MM, Subramaniyam N, Sim CM, Ge X, Sathiakumar D, McFarlane C, Sharma M, Kambadur R. Irisin is a pro-myogenic factor that induces skeletal muscle hypertrophy and rescues denervation-induced atrophy. Nat Commun. 2017 Oct 24;8(1):1104. doi: 10.1038/s41467-017-01131-0.
- Background: PubMed 34576053Nara H, Watanabe R. Anti-Inflammatory Effect of Muscle-Derived Interleukin-6 and Its Involvement in Lipid Metabolism. Int J Mol Sci. 2021 Sep 13;22(18):9889. doi: 10.3390/ijms22189889.
- Background: PubMed 38890783Kamper RS, Nygaard H, Praeger-Jahnsen L, Ekmann A, Ditlev SB, Schultz M, Hansen SK, Hansen P, Pressel E, Suetta C. GDF-15 is associated with sarcopenia and frailty in acutely admitted older medical patients. J Cachexia Sarcopenia Muscle. 2024 Aug;15(4):1549-1557. doi: 10.1002/jcsm.13513. Epub 2024 Jun 18.
- Background: PubMed 31240397Bagheri R, Rashidlamir A, Motevalli MS, Elliott BT, Mehrabani J, Wong A. Effects of upper-body, lower-body, or combined resistance training on the ratio of follistatin and myostatin in middle-aged men. Eur J Appl Physiol. 2019 Sep;119(9):1921-1931. doi: 10.1007/s00421-019-04180-z. Epub 2019 Jun 25.
- Background: PubMed 31431305Tabara Y, Kohara K, Okada Y, Ohyagi Y, Igase M. Creatinine-to-cystatin C ratio as a marker of skeletal muscle mass in older adults: J-SHIPP study. Clin Nutr. 2020 Jun;39(6):1857-1862. doi: 10.1016/j.clnu.2019.07.027. Epub 2019 Aug 6.
- Background: PubMed 35874524Renteria I, Garcia-Suarez PC, Fry AC, Moncada-Jimenez J, Machado-Parra JP, Antunes BM, Jimenez-Maldonado A. The Molecular Effects of BDNF Synthesis on Skeletal Muscle: A Mini-Review. Front Physiol. 2022 Jul 6;13:934714. doi: 10.3389/fphys.2022.934714. eCollection 2022.
- Background: PubMed 36633611Ladang A, Beaudart C, Reginster JY, Al-Daghri N, Bruyere O, Burlet N, Cesari M, Cherubini A, da Silva MC, Cooper C, Cruz-Jentoft AJ, Landi F, Laslop A, Maggi S, Mobasheri A, Ormarsdottir S, Radermecker R, Visser M, Yerro MCP, Rizzoli R, Cavalier E. Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Academique de Recherche et d'Experimentation en Sante (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging. Calcif Tissue Int. 2023 Feb;112(2):197-217. doi: 10.1007/s00223-022-01054-z. Epub 2023 Jan 12.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Michael V Salemi contact
Brittany C Adams principal investigator
Western New England University
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 in people with Healthy, run by Western New England University 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 9 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany C Adams (413-782-1443, brittany.adams@wne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker - Myostatin (time frame: From start of enrollment to the end of treatment at 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208916, which also lists 16 linked publications.
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 6 Oct 2025.