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

Primary Purpose

Skeletal Muscle Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry enriched diet
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Skeletal Muscle Disorder

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Human Metabolic Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blueberry Enriched Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in number of muscle progenitor cells on the imaging hemocytometer from baseline to 6 weeks of blueberry enriched diet
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2020
Last Updated
January 24, 2022
Sponsor
Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04262258
Brief Title
Effects of a Blueberry Enriched Diet on the Skeletal Muscle Regenerative Process
Official Title
Effect of a Blueberry Enriched Diet on Skeletal Muscle Progenitor Cells
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skeletal Muscle Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blueberry Enriched Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry enriched diet
Other Intervention Name(s)
freeze dried blueberries
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of muscle progenitor cells on the imaging hemocytometer from baseline to 6 weeks of blueberry enriched diet
Description
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.
Time Frame
serum is obtained over the course of 6 weeks. Cell number is tracked over 12 days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Human Metabolic Research Unit
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32678436
Citation
Blum JE, Gheller BJ, Hwang S, Bender E, Gheller M, Thalacker-Mercer AE. Consumption of a Blueberry-Enriched Diet by Women for 6 Weeks Alters Determinants of Human Muscle Progenitor Cell Function. J Nutr. 2020 Sep 1;150(9):2412-2418. doi: 10.1093/jn/nxaa190.
Results Reference
derived

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

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