Skeletal Muscle DisorderNCT04262258
Effects of a Blueberry Enriched Diet on the Skeletal Muscle Regenerative Process
A study testing Blueberry enriched diet in people with Skeletal Muscle Disorder, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Disorder
- What is being tested?
- Blueberry enriched diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young 21-40 y women
- old 65-79 y women
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolic Research Unit
Ithaca, New York, 14853
About this study
Official title: 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.
- Conditions
- Skeletal Muscle Disorder
- Being tested
- Blueberry enriched diet
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry enriched dietDietary supplement
Also called freeze dried blueberries
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.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Enriched Diet | Experimental | 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. Receives: Dietary Supplement: Blueberry enriched diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: serum is obtained over the course of 6 weeks. Cell number is tracked over 12 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start29 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skeletal Muscle DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262258
- Sponsor's protocol ID
- 82422
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32678436
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Blueberry Enriched Diet on Skeletal Muscle Progenitor Cells
- ClinicalTrials.gov ID
- NCT04262258
- Acronym / sponsor ID
- 82422
- Conditions
- Skeletal Muscle Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blueberry Enriched Diet | Experimental | Dietary Supplement: Blueberry enriched dietThe 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. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Young 21-40 y women
- old 65-79 y women
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry enriched dietAlso: freeze dried blueberriesThe 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 32678436Blum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry enriched diet in people with Skeletal Muscle Disorder, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.