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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

Primary Purpose

Obesity Associated Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
krill oil (SuperbaBoostTM)
4g/day of mixed vegetable oil
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity Associated Disorder focused on measuring Obesity, Cardiometabolic risk factors, Fat mass, Fat free mass, Body composition, Muscle strength, LCn-3PUFA

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Glasgow, New Lister BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Krill oil capsules (LC n-3 PUFAs)

Vegetable oil capsules

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.
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.
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).
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.

Secondary Outcome Measures

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.
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.
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.
Cardiometabolic risk factor (Triglycerides)
Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).
Cardiometabolic risk factor (Insulin)
ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).
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).

Full Information

First Posted
July 31, 2023
Last Updated
August 17, 2023
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT06001632
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Associated Disorder
Keywords
Obesity, Cardiometabolic risk factors, Fat mass, Fat free mass, Body composition, Muscle strength, LCn-3PUFA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Krill oil capsules (LC n-3 PUFAs)
Arm Type
Experimental
Arm Description
4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.
Arm Title
Vegetable oil capsules
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
krill oil (SuperbaBoostTM)
Intervention Description
4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).
Intervention Type
Dietary Supplement
Intervention Name(s)
4g/day of mixed vegetable oil
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in fat-free mass
Description
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.
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Muscle function by Handgrip strength
Description
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.
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Chair rising test
Description
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).
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Fat mass
Description
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.
Time Frame
4 weeks, 12 weeks, and 20 weeks
Secondary Outcome Measure Information:
Title
Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
Description
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.
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Appetite related hormone [ Peptide YY (PYY)]
Description
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.
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Appetite related hormone [ Acylated Ghrelin]
Description
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.
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Cardiometabolic risk factor (Triglycerides)
Description
Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Cardiometabolic risk factor (Insulin)
Description
ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).
Time Frame
4 weeks, 12 weeks, and 20 weeks
Title
Cardiometabolic risk factor (Glucose)
Description
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).
Time Frame
4 weeks, 12 weeks, and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia Malkova, PhD
Phone
07753433971
Email
Dalia.Malkova@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mansour Alblaji
Phone
07310647742
Email
m.alblaji.1@research.gla.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansour Alblaji
Organizational Affiliation
Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Glasgow, New Lister Building
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansour Alblaji
Phone
07310647742
Email
mansourghazi1411@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study will published in scientific journal upon finished

Learn more about this trial

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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