Obesity Associated DisorderNCT06001632
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
A study testing krill oil (SuperbaBoostTM) and 4g/day of mixed vegetable oil in people with Obesity Associated Disorder, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Associated Disorder
- What is being tested?
- krill oil (SuperbaBoostTM) and 4g/day of mixed vegetable oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2022to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Glasgow, New Lister Building
Glasgow, Scotland, G31 2ER
About this study
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).
Read the 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).
- Conditions
- Obesity Associated Disorder
- Being tested
- krill oil (SuperbaBoostTM), 4g/day of mixed vegetable oil
- Keywords
- Obesity, Cardiometabolic risk factors, Fat mass, Fat free mass, Body composition, Muscle strength, LCn-3PUFA
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
krill oil (SuperbaBoostTM)Dietary supplement
4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).
4g/day of mixed vegetable oilDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Krill oil capsules (LC n-3 PUFAs) | Experimental | 4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline. Receives: Dietary Supplement: krill oil (SuperbaBoostTM) |
| Vegetable oil capsules | Placebo comparator | 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). Receives: Dietary Supplement: 4g/day of mixed vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 4 weeks, 12 weeks, and 20 weeks
Secondary outcomes (6)
Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
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.
Measured: 4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Peptide YY (PYY)]
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.
Measured: 4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Acylated Ghrelin]
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.
Measured: 4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Triglycerides)
Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).
Measured: 4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Insulin)
ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).
Measured: 4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Glucose)
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).
Measured: 4 weeks, 12 weeks, and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Mar 2022
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity Associated DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Mansour Alblaji, Principal investigator, Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001632
- Sponsor's protocol ID
- U Glasgow
- Status last verified
- Oct 2025
- First submitted
- 31 Jul 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will published in scientific journal upon finished
Publications
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.
PubMed 40671417
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06001632
- Acronym / sponsor ID
- U Glasgow
- Conditions
- Obesity Associated Disorder
- Keywords
- Obesity, Cardiometabolic risk factors, Fat mass, Fat free mass, Body composition, Muscle strength, LCn-3PUFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krill oil capsules (LC n-3 PUFAs) | Experimental | Dietary Supplement: krill oil (SuperbaBoostTM)4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline. |
| Vegetable oil capsules | Placebo comparator | Dietary Supplement: 4g/day of mixed vegetable oil4g/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). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| krill oil (SuperbaBoostTM)4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline). | Dietary supplement | Krill oil capsules (LC n-3 PUFAs) |
| 4g/day of mixed vegetable oilvegetable 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). | Dietary supplement | Vegetable oil capsules |
Primary outcome
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.
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.
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).
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.
6 secondary outcomes
Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
Time frame: 4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Peptide YY (PYY)]
Time frame: 4 weeks, 12 weeks, and 20 weeks
Appetite related hormone [ Acylated Ghrelin]
Time frame: 4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Triglycerides)
Time frame: 4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Insulin)
Time frame: 4 weeks, 12 weeks, and 20 weeks
Cardiometabolic risk factor (Glucose)
Time frame: 4 weeks, 12 weeks, and 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 40671417Alblaji 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.
- Individual participant dataSharing planned: No. The study will published in scientific journal upon finished
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansour Alblaji principal investigator
Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing krill oil (SuperbaBoostTM) and 4g/day of mixed vegetable oil in people with Obesity Associated Disorder, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fat-free mass (time frame: 4 weeks, 12 weeks, and 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.