NCT06001632

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 17, 2025

Status Verified

October 1, 2025

Enrollment Period

3.5 years

First QC Date

July 31, 2023

Last Update Submit

December 9, 2025

Conditions

Keywords

ObesityCardiometabolic risk factorsFat massFat free massBody compositionMuscle strengthLCn-3PUFA

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)

EXPERIMENTAL

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

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).

Dietary Supplement: 4g/day of mixed vegetable oil

Interventions

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).

Krill oil capsules (LC n-3 PUFAs)

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).

Vegetable oil capsules

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mansour Alblaji

    Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow

    PRINCIPAL INVESTIGATOR

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

Locations