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Effects of a Blueberry Enriched Diet on the Skeletal Muscle Regenerative Process

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262258
Recruitment Status : Completed
First Posted : February 10, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Thalacker-Mercer, Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skeletal Muscle Disorder Dietary Supplement: Blueberry enriched diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a Blueberry Enriched Diet on Skeletal Muscle Progenitor Cells
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.
Dietary Supplement: 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.
Other Name: freeze dried blueberries




Primary Outcome Measures :
  1. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262258


Locations
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United States, New York
Human Metabolic Research Unit
Ithaca, New York, United States, 14853
Sponsors and Collaborators
Cornell University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Thalacker-Mercer, Assistant Professor, Cornell University
ClinicalTrials.gov Identifier: NCT04262258    
Other Study ID Numbers: 82422
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases