Healthy
Conditions
Keywords
grapes, diet, muscle strength, cognition, sarcopenia, serum biomarkers, women
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
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_SUPPLEMENTGrape 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.
Sponsors
Western New England University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker - CAF | From start of enrollment through the end of treatment at 4 weeks | Through serum analysis, biomarker C-terminal fragment of agrin (CAF) will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - IL-6 | From start of enrollment through treatment at week 4 | Through serum analysis, Interleukin-6 (IL-6) will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - GDF-15 | From start of enrollment to the end of treatment at 4 weeks | Through serum analysis, Growth Differentiation Factor 15 (GDF-15) will be measured in units of pg/mL at three points throughout the study. |
| BIomarker - BDNF | From start of enrollment through end of treatment at 4 weeks | Through serum analysis, Brain-derived neurotrophic factor (BDNF) will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - Cystatin C | From start of enrollment through the end of treatment at 4 weeks | Through serum analysis, biomarker Cystatin C will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - TNF-α | From start of enrollment through the end of treatment at 4 weeks | Through serum analysis, biomarker Tumor necrosis factor-alpha will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - CRP | From start of enrollment through the end of treatment at 4 weeks | Through serum analysis, biomarker C-reactive protein (CRP) will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - CCL-2/MCP-1 | From start of enrollment through the end of treatment at 4 weeks | Through serum analysis, biomarker C-C motif chemokine ligand 2 / Monocyte chemoattractant protein 1 will be measured in units of pg/mL at three points throughout the study. |
| Biomarker - Malondialdehyde | From start of enrollment through the end of treatment at 4 weeks | Through serum analysis, biomarker malondialdehyde will be measured in units of µM at three points throughout the study. |
| Biomarker - Myostatin | From start of enrollment to the end of treatment at 4 weeks | Through serum analysis, myostatin will be measured in units of pg/mL at three points throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Muscle Strength - Bilateral Grip Strength | From start of enrollment to the end of treatment at 4 weeks | Bilateral Grip Strength -Hydraulic Hand Dynamometer - a reliable indicator of overall muscular strength and has been correlated with functional status and health outcomes in older adults. |
| Functional Muscle Strength - Bilateral Pinch Strength | From start of enrollment to the end of treatment at 4 weeks | Bilateral Pinch Strength -Hydraulic Pinch Gauge - provide insight into fine motor function and hand dexterity, which are crucial for daily activities. |
| Functional Muscle Strength - Standing Balance | From start of enrollment to the end of treatment at 4 weeks | Standing Balance - Timed Up and Go (TUG) Test - a quick and effective measure of mobility and balance, predicting fall risk in older populations. |
| Functional Muscle Strength - Overall Physical Performance | From start of enrollment to the end of treatment at 4 weeks | Overall Physical Performance - Short Physical Performance Battery (SPPB) -evaluates lower extremity function through balance, gait speed, and chair stand tests. It is a validated tool for assessing physical performance and predicting disability and mortality in older adults. |
| Functional Muscle Strength - Self-Reported Instrumental Activities of Daily Living | From start of enrollment to the end of treatment at 4 weeks | Self-Reported Instrumental Activities of Daily Living - Lawton-Brody IADL Scale - assesses an individual's ability to perform complex daily tasks, providing insight into functional independence. |
| Body Composition Total Score | From start of enrollment to the end of treatment at 4 weeks | A body composition total score is an indicator of an individual's overall health by quantifying their body's components (fat, muscle, bone, and water) and providing a numerical rating, often out of 100, that serves as a health risk indicator. A body composition analysis machine will be used for this calculation. |
| Functional Cognition | From start of enrollment to the end of treatment at 4 weeks | Montreal Cognitive Assessment (MoCA) - a brief cognitive screening tool that effectively detects mild cognitive impairment, offering greater sensitivity than other instruments like the MMSE. It assesses multiple cognitive domains and is validated for use in older populations. |
Countries
United States
Contacts
Primary ContactBrittany C Adams
Backup ContactMichael V Salemi
Outcome results
None listed