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
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2022
CompletedFirst Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedDecember 17, 2025
October 1, 2025
3.5 years
July 31, 2023
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in fat-free mass
To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat-free mass. The changes in fat-free mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat-free mass (FFM) in kg. The investigators will take two saliva samples from participants in each visit.
4 weeks, 12 weeks, and 20 weeks
Muscle function by Handgrip strength
The Jamar hydraulic Hand dynamometer, which is a portable instrument used in clinical and research settings to precisely measure grip strength and hand function, will be used to measure handgrip strength. It has an adjustable handle that contains five grip position to suit different hand sizes and preferences. It measures the amount of force that a hand can squeeze around the dynamometer, which in term used to predict the overall muscle strength. The hand-held hydraulic system contains a measurement range of 0 to 200 pounds of force (0 to 90 kilograms), making it appropriate for testing hand grip strength. The dynamometer will be adjusted for participant's hand size. Then, the participant will be asked to perform as much grip pressure as possible for two to three seconds. The subjects will receive verbal guidance from the examiner to start and finish the grip test.
4 weeks, 12 weeks, and 20 weeks
Chair rising test
The chair rising test will be used to asses physical performance. The subjects will be asked to sit on a chair without armrests and perform a rising from a chair to a full standing position (standing fully erect to a straight and upright position) and then sitting down again as quickly as possible five times with recording time, with arms folded across the chest. The chair rising test will be based on seconds (s).
4 weeks, 12 weeks, and 20 weeks
Fat mass
To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat mass. The changes in fat mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat mass in kg. The investigators will take two saliva samples from participants in each visit.
4 weeks, 12 weeks, and 20 weeks
Secondary Outcomes (6)
Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Peptide YY (PYY)]
4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Acylated Ghrelin]
4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Triglycerides)
4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Insulin)
4 weeks, 12 weeks, and 20 weeks
- +1 more secondary outcomes
Study Arms (2)
Krill oil capsules (LC n-3 PUFAs)
EXPERIMENTAL4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.
Vegetable oil capsules
PLACEBO COMPARATOR4g/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).
Interventions
4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).
vegetable oil capsules (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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Glasgow, New Lister Building
Glasgow, Scotland, G31 2ER, United Kingdom
Related Publications (1)
Alblaji M, Gray SR, Almesbehi T, Morrison DJ, Malkova D. Benefits of Krill Oil Supplementation During Alternate-Day Fasting in Adults With Overweight and Obesity: A Randomized Trial. Obesity (Silver Spring). 2025 Sep;33(9):1694-1703. doi: 10.1002/oby.24354. Epub 2025 Jul 16.
PMID: 40671417DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mansour Alblaji
Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 21, 2023
Study Start
March 28, 2022
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
December 17, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
The study will published in scientific journal upon finished