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

Official title

Evaluation of Grape Consumption to Improve Muscle Strength and Cognitive Function

Overview

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.

Interventions

• Dietary supplement Grape Powder
  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.

Primary outcome measures

• Biomarker - Myostatin [Time frame: From start of enrollment to the end of treatment at 4 weeks]
• Biomarker - IL-6 [Time frame: From start of enrollment through treatment at week 4]
• Biomarker - GDF-15 [Time frame: From start of enrollment to the end of treatment at 4 weeks]
• BIomarker - BDNF [Time frame: From start of enrollment through end of treatment at 4 weeks]
• Biomarker - Cystatin C [Time frame: From start of enrollment through the end of treatment at 4 weeks]
• Biomarker - TNF-α [Time frame: From start of enrollment through the end of treatment at 4 weeks]
• Biomarker - CRP [Time frame: From start of enrollment through the end of treatment at 4 weeks]
• Biomarker - CCL-2/MCP-1 [Time frame: From start of enrollment through the end of treatment at 4 weeks]
• Biomarker - CAF [Time frame: From start of enrollment through the end of treatment at 4 weeks]
• Biomarker - Malondialdehyde [Time frame: From start of enrollment through the end of treatment at 4 weeks]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Keloid formation
• Chronic renal or hepatic disorder
• Significant bleeding disorder
• Progressive neurodegenerative condition
• Swallowing disorder
• OTHER

a. 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.

b. 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Western New England University — Springfield

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. PMID 31650623
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07208916 · WNEIRB001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗