- ICH GCP
- US Clinical Trials Registry
- 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
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G31 2ER
- University of Glasgow, New Lister Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Mansour Alblaji, Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U Glasgow
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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