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

Obesity Associated Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001632
• Other study ID #: U Glasgow
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: November 20, 2024

Study information

• Verified date: April 2024
• Source: University of Glasgow
• Contact: Dalia Malkova, PhD
• Phone: 07753433971
• Email: Dalia.Malkova[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 20, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity Associated Disorder
• Overweight

Intervention

Dietary Supplement:
• krill oil (SuperbaBoostTM)
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 oil
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).

Locations

Country	Name	City	State
United Kingdom	University of Glasgow, New Lister Building	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	4 weeks, 12 weeks, and 20 weeks
Secondary	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.	4 weeks, 12 weeks, and 20 weeks
Secondary	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.	4 weeks, 12 weeks, and 20 weeks
Secondary	Cardiometabolic risk factor (Triglycerides)	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
Secondary	Cardiometabolic risk factor (Insulin)	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
Secondary	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).	4 weeks, 12 weeks, and 20 weeks