Evaluation of the Potential of Grape Consumption to Improve Muscle Strength and Cognitive Function

NCT07208916 | Recruiting

• 1 other identifier: WNEIRB001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 asked to take part in 4 sessions on campus. Each session will include: Functional muscle strength testing Cognitive testing Blood draws

Conditions

Healthy

Keywords

grapes; diet; muscle strength; cognition; sarcopenia; serum biomarkers; women

Outcome Measures

Primary Outcomes (10)

• Biomarker - Myostatin

  Through serum analysis, myostatin will be measured in units of pg/mL at three points throughout the study.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From start of enrollment through the end of treatment at 4 weeks

Secondary Outcomes (7)

• Functional Cognition

  From start of enrollment to the end of treatment at 4 weeks

• Functional Muscle Strength - Bilateral Grip Strength

  From start of enrollment to the end of treatment at 4 weeks

• Functional Muscle Strength - Bilateral Pinch Strength

  From start of enrollment to the end of treatment at 4 weeks

• Functional Muscle Strength - Standing Balance

  From start of enrollment to the end of treatment at 4 weeks

• Functional Muscle Strength - Overall Physical Performance

  From start of enrollment to the end of treatment at 4 weeks

Study Arms (1)

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.

Dietary Supplement: Grape Powder

Interventions

Grape Powder DIETARY_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.

Grape Powder Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Western New England University: lead

Study Sites (1)

Western New England University

Springfield, Massachusetts, 01119, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 31650623 BACKGROUND

• Graf C. The Lawton Instrumental Activities of Daily Living (IADL) Scale. Medsurg Nurs. 2009 Sep-Oct;18(5):315-6. No abstract available.

  PMID: 19927971 BACKGROUND

• Phu 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.

  PMID: 32660438 BACKGROUND

• Leger, 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

• 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.

  PMID: 11243558 BACKGROUND

• Reza 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.

  PMID: 29062100 BACKGROUND

• Nara 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.

  PMID: 34576053 BACKGROUND

• Kamper 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.

  PMID: 38890783 BACKGROUND

• Bagheri 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.

  PMID: 31240397 BACKGROUND

• Tabara 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.

  PMID: 31431305 BACKGROUND

• Renteria 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.

  PMID: 35874524 BACKGROUND

• Ladang 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.

  PMID: 36633611 BACKGROUND

• Rosner B. Fundamentals of Biostatistics. 7th ed. Boston, MA: Brooks/Cole; 2011.

  BACKGROUND

• 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.

  PMID: 21475695 BACKGROUND

• Maher, P. Grapes and the Brain. In Grapes and Health; Pezzuto, J.M., Ed.; Springer International Publishing: Cham, Switzerland, 2016; pp. 139-161.

  BACKGROUND

• Pezzuto JM. Grapes and human health: a perspective. J Agric Food Chem. 2008 Aug 27;56(16):6777-84. doi: 10.1021/jf800898p. Epub 2008 Jul 29.

  PMID: 18662007 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

whole grape extract

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

• Brittany C Adams

  Western New England University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany C Adams

CONTACT

413-782-1443; brittany.adams@wne.edu

Michael V Salemi

CONTACT

michael.salemi@wne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 6, 2025
• Study Start: September 9, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: Reasonable requests submitted to the corresponding author of any publications will be honored.

Locations

US (1)