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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
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.
Western New England University
Springfield, Massachusetts, United States
RECRUITINGBiomarker - Myostatin
Through serum analysis, myostatin will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Biomarker - IL-6
Through serum analysis, Interleukin-6 (IL-6) will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment through treatment at week 4
Biomarker - GDF-15
Through serum analysis, Growth Differentiation Factor 15 (GDF-15) will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment to the end of treatment at 4 weeks
BIomarker - BDNF
Through serum analysis, Brain-derived neurotrophic factor (BDNF) will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment through end of treatment at 4 weeks
Biomarker - Cystatin C
Through serum analysis, biomarker Cystatin C will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment through the end of treatment at 4 weeks
Biomarker - TNF-α
Through serum analysis, biomarker Tumor necrosis factor-alpha will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment through the end of treatment at 4 weeks
Biomarker - CRP
Through serum analysis, biomarker C-reactive protein (CRP) will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment through the end of treatment at 4 weeks
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Biomarker - CCL-2/MCP-1
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.
Time frame: From start of enrollment through the end of treatment at 4 weeks
Biomarker - CAF
Through serum analysis, biomarker C-terminal fragment of agrin (CAF) will be measured in units of pg/mL at three points throughout the study.
Time frame: From start of enrollment through the end of treatment at 4 weeks
Biomarker - Malondialdehyde
Through serum analysis, biomarker malondialdehyde will be measured in units of µM at three points throughout the study.
Time frame: From start of enrollment through the end of treatment at 4 weeks
Functional Cognition
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.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Bilateral Grip Strength
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.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Bilateral Pinch Strength
Bilateral Pinch Strength -Hydraulic Pinch Gauge - provide insight into fine motor function and hand dexterity, which are crucial for daily activities.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Standing Balance
Standing Balance - Timed Up and Go (TUG) Test - a quick and effective measure of mobility and balance, predicting fall risk in older populations.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Overall Physical Performance
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.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Functional Muscle Strength - Self-Reported Instrumental Activities of Daily Living
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.
Time frame: From start of enrollment to the end of treatment at 4 weeks
Body Composition Total Score
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.
Time frame: From start of enrollment to the end of treatment at 4 weeks