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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

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ClinicalTrials.gov Identifier: NCT06001632
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Dr Dalia Malkova, University of Glasgow

Study Description
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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).


Condition or disease Intervention/treatment Phase
Obesity Associated Disorder Dietary Supplement: krill oil (SuperbaBoostTM) Dietary Supplement: 4g/day of mixed vegetable oil Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : April 25, 2024
Estimated Study Completion Date : November 20, 2024
Arms and Interventions
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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.
 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).
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).
 Dietary Supplement: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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. 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).

  5. 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).

  6. 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).



Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001632


Contacts
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Contact: Dalia Malkova, PhD 07753433971 Dalia.Malkova@glasgow.ac.uk
Contact: Mansour Alblaji 07310647742 m.alblaji.1@research.gla.ac.uk

Locations
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United Kingdom
University of Glasgow, New Lister Building Recruiting
Glasgow, Scotland, United Kingdom, G31 2ER
Contact: Mansour Alblaji    07310647742    mansourghazi1411@gmail.com   
Sponsors and Collaborators
University of Glasgow
Investigators
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Principal Investigator: Mansour Alblaji Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
More Information
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Responsible Party: Dr Dalia Malkova, Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow, University of Glasgow
ClinicalTrials.gov Identifier: NCT06001632    
Other Study ID Numbers: U Glasgow
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study will published in scientific journal upon finished

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Dalia Malkova, University of Glasgow:
Obesity
Cardiometabolic risk factors
Fat mass
Fat free mass
 Body composition
Muscle strength
LCn-3PUFA
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight