Eating grapes to improve muscle strength and thinking in women over 65.

Evaluation of Grape Consumption to Improve Muscle Strength and Cognitive Function

We will test whether eating grape powder every day helps muscle strength and thinking in women aged 65 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 65 Years and up
• Sex: Female
• Sponsor: Western New England University (other)
• Drugs / interventions: chemotherapy, methotrexate
• Locations: 1 site (Springfield, Massachusetts)
• Trial ID: NCT07208916 on ClinicalTrials.gov

What this trial studies

This translational, interventional project will recruit 35 generally healthy women aged 65+ to measure whether daily grape powder affects functional muscle strength and cognitive performance. After a two-week run-in diet, participants complete baseline strength and cognitive tests and blood draws, then take two 36 g pouches of grape powder daily (about three servings of fresh grapes) for 30 days. Strength, cognitive testing, and blood sampling are repeated at Day 28 and Day 42 to track changes and serum markers. The design aims to link functional outcomes with biological markers to inform future larger trials.

Who should consider this trial

Good fit: Ideal candidates are healthy, non-smoking women aged 65 or older who can walk household distances unaided, have dominant hand grip strength at or below the normal value for age and can comply with study visits and dietary restrictions.

Not a fit: People who are younger than 65, male, have significant medical conditions, use excluded medications or supplements, are unable to travel to campus visits, or who do not follow the diet are unlikely to benefit from this specific study.

Why it matters

Potential benefit: If successful, regular grape intake could offer a simple dietary approach to help maintain or improve muscle strength and thinking in older women.

How similar studies have performed: Some animal studies and small human nutrition studies suggest grape-derived polyphenols may help muscle and brain health, but controlled human data remain limited.

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:

  1. Major surgery for any indication
  2. On cytotoxic chemotherapy for any indication (including methotrexate for arthritis)
  3. Hormonal therapy for cancer prevention (including tamoxifen). Note: treatment with finasteride/dutasteride for BPH does not render a participant ineligible
  4. 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:

  1. Hepatitis;
  2. Diabetes (including insulin injections);
  3. Solid organ or bone marrow transplant
  4. Keloid formation
  5. Chronic renal or hepatic disorder
  6. Significant bleeding disorder
  7. Progressive neurodegenerative condition
  8. 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

Where this trial is running

Springfield, Massachusetts

• Western New England University — Springfield, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Brittany C Adams — Western New England University
• Study coordinator: Brittany C Adams

Conditions: Healthy, grapes, diet, muscle strength, cognition, sarcopenia, serum biomarkers, women