Clinical trial NCT06001632: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity Associated Disorder
Keywords: Obesity
Cardiometabolic risk factors
Fat mass
Fat free mass
Body composition
Muscle strength
LCn-3PUFA
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in fat-free mass
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Muscle function by Handgrip strength
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Chair rising test
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Fat mass
timeFrame: 4 weeks, 12 weeks, and 20 weeks
Secondary outcomes:
measure: Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Appetite related hormone [ Peptide YY (PYY)]
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Appetite related hormone [ Acylated Ghrelin]
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Cardiometabolic risk factor (Triglycerides)
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Cardiometabolic risk factor (Insulin)
timeFrame: 4 weeks, 12 weeks, and 20 weeks
measure: Cardiometabolic risk factor (Glucose)
timeFrame: 4 weeks, 12 weeks, and 20 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow, New Lister Building
state: Scotland
Study officials:
affiliation: Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
name: Mansour Alblaji
role: PRINCIPAL_INVESTIGATOR
References: