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

NCT ID: NCT07208916

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Grape Powder

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western New England University

OTHER

Sponsor Role lead

Responsible Party

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Brittany Adams

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brittany C Adams

Role: PRINCIPAL_INVESTIGATOR

Western New England University

Locations

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Western New England University

Springfield, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brittany C Adams

Role: CONTACT

413-782-1443

Michael V Salemi

Role: CONTACT

Facility Contacts

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Brittany C Adams

Role: primary

413-782-1443

Michael Salemi

Role: backup

References

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Other Identifiers

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WNEIRB001

Identifier Type: -

Identifier Source: org_study_id

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