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

December 9, 2025 updated by: Dr Dalia Malkova, University of Glasgow

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).

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • University of Glasgow, New Lister Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Krill oil capsules (LC n-3 PUFAs)
4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.
4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).
Placebo Comparator: Vegetable oil capsules
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fat-free mass
Time Frame: 4 weeks, 12 weeks, and 20 weeks

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
Time Frame: 4 weeks, 12 weeks, and 20 weeks

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
Time Frame: 4 weeks, 12 weeks, and 20 weeks

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
Time Frame: 4 weeks, 12 weeks, and 20 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
Time Frame: 4 weeks, 12 weeks, and 20 weeks

The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (GLP-1).

The measurements of Plasma GLP-1 concentrations will be determined using the ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).by All analyses will be performed according to the manufacturer's protocol and instructions.

4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Peptide YY (PYY)]
Time Frame: 4 weeks, 12 weeks, and 20 weeks

The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (PYY).

The measurements of Plasma PYY concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).

All analyses will be performed according to the manufacturer's protocol and instructions.

4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Acylated Ghrelin]
Time Frame: 4 weeks, 12 weeks, and 20 weeks

The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on hunger hormone (Acylated Ghrelin).

The measurements of Plasma Acylated Ghrelin concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).

All analyses will be performed according to the manufacturer's protocol and instructions.

4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Triglycerides)
Time Frame: 4 weeks, 12 weeks, and 20 weeks
Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).
4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Insulin)
Time Frame: 4 weeks, 12 weeks, and 20 weeks
ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).
4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Glucose)
Time Frame: 4 weeks, 12 weeks, and 20 weeks

Glucose levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).

HOMA-IR values will be calculated using the equation developed by Matthews and colleagues (Matthews, 1985).

4 weeks, 12 weeks, and 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mansour Alblaji, Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study will published in scientific journal upon finished

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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