Status:
RECRUITING
Evaluation of the Potential of Grape Consumption to Improve Muscle Strength and Cognitive Function
Lead Sponsor:
Western New England University
Conditions:
Healthy
Eligibility:
FEMALE
65+ years
Phase:
NA
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 ...
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 examin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07208916
Start Date
September 9 2025
End Date
April 30 2026
Last Update
October 6 2025
Active Locations (1)
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1
Western New England University
Springfield, Massachusetts, United States, 01119