Recruiting

Grapes

Sponsor:

Western New England University

Code:

NCT07208916

Conditions

Healthy

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Accepted

Interventions

Grape Powder

Study Details

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

Study ID

NCT07208916

Start date

Sep 9, 2025

Status verified date

Oct, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Grape Powder Arm

All subjects will consume two 36g packets of grape powder (mixed with water) daily for two, 2-week periods during the study.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Western New England University

Recruiting

Springfield, Massachusetts, United States, 01119

Contacts

Principal Investigator:

Brittany C Adams

More Information

Sponsor

Western New England University

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western New England University on 2025-10-06.