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

University of Glasgow

Status: Completed

Conditions: Obesity Associated Disorder

Treatments: Dietary Supplement: 4g/day of mixed vegetable oil; Dietary Supplement: krill oil (SuperbaBoostTM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06001632

U Glasgow

Details and patient eligibility

About

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).

Full description

During the preparation phase, participants will be asked to take 4g/d krill oil capsules or placebo oil (mixed vegetable oil) with their healthy diet (their usual diet) for a period of 4 weeks. After the completion of the four weeks of the preparation phase, the weight loss intervention (Alternate Day Fasting) will start, and it last for eight weeks. Then, after the weight loss intervention, the weight maintenance phase will start, and it takes a period of 8 weeks until the end of the trial (20 weeks - study completion).

Enrollment: 50 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Krill oil capsules (LC n-3 PUFAs)

Experimental group

Description:

4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.

Treatment:

Dietary Supplement: krill oil (SuperbaBoostTM)

Vegetable oil capsules

Placebo Comparator group

Description:

4g/day of mixed vegetable oil (a mixture of olive oil (extra virgin, cold-pressed), maize oil (refined), palm kernel oil (refined) and medium-chain triglycerides, in the ratio 4:4:3:2).

Treatment:

Dietary Supplement: 4g/day of mixed vegetable oil