TerminatedNot Applicable

n3 PUFA and Muscle-disuse Atrophy in Older Women

Stopped: Funding

Canada8 participantsStarted 2019-02-18

Plain-language 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.

Who can participate

Age range

55 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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®). Exclusion Criteria: * 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 * Excessive alcohol consumption (\>21 units/week) * Prior gastrointestinal b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Muscle Cross-Sectional Area

Timeframe: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

Trial details

NCT IDNCT03808519

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-01

View on ClinicalTrials.gov More Muscle Atrophy trials