CompletedNot Applicable

Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity

United Kingdom50 participantsStarted 2022-03-28

Plain-language summary

The goal of this double-blind, randomised, controlled trial is to determine the effects of LC n-3 PUFAs supplementation on changes in body composition and muscle strength during body weight loss and body weight maintenance among healthy adults living with overweight and obesity. The main research questions: * Is supplementation with LC n-3 PUFAs during dietary weight loss intervention (alternative-day fasting) attenuate the reduction in fat-free mass and muscle strength? * Is supplementation with LC n-3 PUFAs during dietary weight loss intervention (alternative-day fasting) provide additional impact on appetite related hormones (Acylated ghrelin, GLP-1, and PYY) and cardiometabolic risk factors (Post prandial inflammatory markers and Triglycerides)? Participants will be randomly assigned to a PLACEBO (Mix-vegetables oil) or LC n-3 PUFAs group (krill oil) (1:1 basis). Both groups will follow a dietary weight loss intervention (Alternate-day fasting). The study will last for 20 weeks that divided into 3 phases: four weeks of the preparation phase, eight weeks of body weight loss phase (Alternate Day Fasting), followed by eight weeks of body weight maintenance phase (regular diet).

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

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: * Healthy (male/female) * body mass index (BMI) of 25 - 39.9 kg/m2 * Aged between 25 and 65 years * stable body weight for at least three months Exclusion Criteria: * Smokers * Food allergy * On any dietary supplements or dietary regimes at the time of the study * Participants with systolic/diastolic \<90/60 mmHg and \>140/90 mmHg

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

Changes in fat-free mass

Timeframe: 4 weeks, 12 weeks, and 20 weeks

Muscle function by Handgrip strength

Timeframe: 4 weeks, 12 weeks, and 20 weeks

Chair rising test

Timeframe: 4 weeks, 12 weeks, and 20 weeks

Fat mass

Timeframe: 4 weeks, 12 weeks, and 20 weeks

Trial details

NCT IDNCT06001632

SponsorUniversity of Glasgow

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Obesity Associated Disorder trials

Plain-language summary

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

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