- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262258
Effects of a Blueberry Enriched Diet on the Skeletal Muscle Regenerative Process
January 24, 2022 updated by: Cornell University
Effect of a Blueberry Enriched Diet on Skeletal Muscle Progenitor Cells
One of the greatest challenges faced by older adults is maintaining physical function and strength with aging.
Deterioration of skeletal muscle with aging leads to loss of mobility, decreased quality of life, and ultimately loss of independence.
Skeletal muscle deterioration with aging is multifactorial, with a key factor being impaired skeletal muscle regeneration following damage.
Muscle regeneration is a multistep process that requires a viable population of skeletal muscle specific progenitor cells (MPCs).
MPCs reside in the skeletal muscle in a dormant state until activated by stress or injury cues.
Upon activation, MPCs divide, commit to the muscle cell lineage, and fuse to form new multinucleated cells or repair damaged muscle cells.
In older adults this regenerative process is impaired, which amplifies skeletal muscle deterioration.
The investigators demonstrated that the ability of MPCs to divide (proliferate) is reduced, while MPC death is elevated in MPCs from healthy older adults.
Further, the investigators have demonstrated that impaired nutrient metabolism, cellular inflammation, and oxidative stress are key mechanisms in this age-related disruption of MPC proliferation and overall skeletal muscle health.
Therapies that improve the regenerative process and nutrient metabolism as well as attenuate oxidative stress and inflammation are necessary to improve overall skeletal muscle health of older adults.
Blueberries have properties that the investigators hypothesize will improve the proliferative capacity (increase cell division and reduce cell death) of MPCs.
Additionally, the investigators hypothesize that consumption of blueberries will improve skeletal muscle regeneration in the aging population via improved nutrient metabolism, attenuated cellular inflammation, and reduction of oxidative stress.
The hypotheses will be tested using a dietary blueberry intervention.
Serum from our human subjects [blueberry enriched diet (BED)-serum] will be collected and used to treat primary human MPCs.
Ultimately, the investigators hypothesize that a blueberry enriched diet provides an ideal, natural therapy to improve MPC proliferative capacity, which is necessary to attenuate skeletal muscle deterioration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Ithaca, New York, United States, 14853
- Human Metabolic Research Unit
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Young 21-40 y women
- old 65-79 y women
Exclusion Criteria:
- known musculoskeletal disease (e.g., rheumatoid arthritis)
- movement disorder (e.g., Parkinson's disease) or other disorder that might affect skeletal muscle mass, function, or metabolism (e.g. diabetes, cancer)
- obese (BMI ≥ 30.0 kg/m2)
- long-term treatment with exogenous hormones or other pharmacological interventions -known to or that have the potential to influence muscle mass or function (e.g. glucocorticoids)
- antibiotic use within 6 months of intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Blueberry Enriched Diet
The blueberry intervention will consist of participants ingesting two servings of 19 g freeze dried blueberry powder (equivalent to 250 g whole blueberries) daily for six weeks.
Subjects will ingest the freeze dried blueberries orally.
Freeze dried blueberry powder will be mixed with 8-10 ounces of water and consumed.
Subjects will be asked to rinse the cup to wash any remaining blueberries off of the cup and consume the rinse water.
Subjects will be given a two week supply at baseline (week 0) and a four week supply when they return for their blood draw at week 2. Subjects will be asked to return empty packets and check-off daily records as a measure of compliance.
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The blueberry intervention will consist of participants ingesting two servings of 19 g freeze dried blueberry powder (equivalent to 250 g whole blueberries) daily for six weeks.
Subjects will ingest the freeze dried blueberries orally.
Freeze dried blueberry powder will be mixed with 8-10 ounces of water and consumed.
Subjects will be asked to rinse the cup to wash any remaining blueberries off of the cup and consume the rinse water.
Subjects will be given a two week supply at baseline (week 0) and a four week supply when they return for their blood draw at week 2. Subjects will be asked to return empty packets and check-off daily records as a measure of compliance.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of muscle progenitor cells on the imaging hemocytometer from baseline to 6 weeks of blueberry enriched diet
Time Frame: serum is obtained over the course of 6 weeks. Cell number is tracked over 12 days.
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Serum obtained from women consuming the blueberry enriched diet will be pooled.
Cultured muscle progenitor cells (in vitro) from young and old women (obtained from a previous study) will be treated with serum from women consuming the blueberry enriched diet.
The number of cells counted will be used as a marker of cell proliferation.
Cell number will be measured using a hemocytometer.
|
serum is obtained over the course of 6 weeks. Cell number is tracked over 12 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 29, 2017
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
January 27, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (ACTUAL)
February 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 7, 2022
Last Update Submitted That Met QC Criteria
January 24, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82422
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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