Muscle AtrophyNCT03808519
n3 PUFA and Muscle-disuse Atrophy in Older Women
A study testing n3 PUFA-enriched fish oil in people with Muscle Atrophy and Muscle Disuse Atrophy, run by McMaster University at 1 site in Canada.
Trial summary
This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy, Muscle Disuse Atrophy, Sarcopenia
- What is being tested?
- n3 PUFA-enriched fish oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2019to 1 Jul 2021
- 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 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Aged 55 - 75 years old
- non-smoking (for at least 2 years)
- > 5 years post-menopausal
- Body mass index (BMI) between 22 and 33 kg/m2
- Mini-Mental State Exam (MMSE) score > 20
- Acceptable medications include: Angiotensin Converting Enzyme (ACE), Beta-Blockers, Acetylsalicylic Acid, Calcium Channel blockers, Depression/Anxiety meds, Bisphosphonates (Fosamax®, Didrocal®, Actonel®, Aclasta®).
Who cannot join
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements.
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer, or carcinoma in situ with no significant progression over the past 2 years.
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral n-3 PUFA supplement ingestion and/or assessment of safety and study objectives
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
- Participation in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study
- Hypersensitivity to the test product
Show all 11Show fewer
- Excessive alcohol consumption (>21 units/week)
- Prior gastrointestinal bypass surgery
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy
- Personal or family history of clotting disorder or deep vein thrombosis
- Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Older Women
This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.
Read the detailed description
Biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. Throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. More importantly, older adults (especially older women) that experience periods of muscle disuse are unable to recover muscle mass and strength. The losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse.
Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. Fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. A previous study from our group demonstrated that younger women supplementing with n3 PUFA-enriched fish oil attenuated declines in skeletal muscle mass and strength during 2 weeks of immobilization. However, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization in older women.
- Conditions
- Muscle Atrophy, Muscle Disuse Atrophy, Sarcopenia
- Being tested
- n3 PUFA-enriched fish oil, Placebo
- Keywords
- n3 PUFA
- Medical subject headings
- Muscular Atrophy, Muscular Disorders, Atrophic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n3 PUFA-enriched fish oilDietary supplement
3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
PlaceboDietary supplement
Organic Sunflower Oil 5000mg per day
| Study group | Role | What they receive |
|---|---|---|
| n3 PUFA | Experimental | n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day) Receives: Dietary Supplement: n3 PUFA-enriched fish oil |
| Placebo | Placebo comparator | Organic Sunflower Oil 5000mg per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Cross-Sectional Area
Changes in muscle cross-sectional area assessed by ultrasonography
Measured: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Secondary outcomes (4)
Integrated rates of muscle protein synthesis
Change in muscle protein synthesis using doubly labelled water (D2O)
Measured: pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Skeletal muscle strength
Change in skeletal muscle strength using the Biodex Dynamometer
Measured: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Endothelial function
Change in flow-mediated dilation
Measured: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Vascular function
Change in total femoral flow
Measured: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start18 Feb 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808519
- Sponsor's protocol ID
- HiREB 1932
- Status last verified
- Oct 2024
- First submitted
- 14 Jan 2019
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Older Women
- ClinicalTrials.gov ID
- NCT03808519
- Acronym / sponsor ID
- HiREB 1932
- Conditions
- Muscle Atrophy, Muscle Disuse Atrophy, Sarcopenia
- Keywords
- n3 PUFA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 17 Jan 2019 (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.
This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.
Detailed description
Biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. Throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. More importantly, older adults (especially older women) that experience periods of muscle disuse are unable to recover muscle mass and strength. The losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse.
Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. Fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. A previous study from our group demonstrated that younger women supplementing with n3 PUFA-enriched fish oil attenuated declines in skeletal muscle mass and strength during 2 weeks of immobilization. However, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization in older women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n3 PUFA | Experimental | Dietary Supplement: n3 PUFA-enriched fish oiln3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOrganic Sunflower Oil 5000mg per day |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Aged 55 - 75 years old
- non-smoking (for at least 2 years)
- > 5 years post-menopausal
- Body mass index (BMI) between 22 and 33 kg/m2
Key exclusion criteria (11 listed)
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements.
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer, or carcinoma in situ with no significant progression over the past 2 years.
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral n-3 PUFA supplement ingestion and/or assessment of safety and study objectives
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
- Participation in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study
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 |
|---|---|---|
| n3 PUFA-enriched fish oil3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day | Dietary supplement | n3 PUFA |
| PlaceboOrganic Sunflower Oil 5000mg per day | Dietary supplement | Placebo |
Primary outcome
Muscle Cross-Sectional Area
Time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Changes in muscle cross-sectional area assessed by ultrasonography
4 secondary outcomes
Integrated rates of muscle protein synthesis
Time frame: pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Skeletal muscle strength
Time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Endothelial function
Time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Vascular function
Time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Stuart M Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n3 PUFA-enriched fish oil in people with Muscle Atrophy and Muscle Disuse Atrophy, run by McMaster University at 1 site in Canada.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Funding). Results are not available in the source record.
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?
Muscle Cross-Sectional Area (time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.