Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 4:14 AM
Study NCT ID:
NCT06001632
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2023-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fat-free mass', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': 'To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat-free mass.\n\nThe 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.\n\nThe investigators will take two saliva samples from participants in each visit.'}, {'measure': 'Muscle function by Handgrip strength', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', '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.\n\nThe 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."}, {'measure': 'Chair rising test', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', '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.\n\nThe chair rising test will be based on seconds (s).'}, {'measure': 'Fat mass', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': 'To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat mass.\n\nThe 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.\n\nThe investigators will take two saliva samples from participants in each visit.'}], 'secondaryOutcomes': [{'measure': 'Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': "The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (GLP-1).\n\nThe 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."}, {'measure': 'Appetite related hormone [ Peptide YY (PYY)]', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': "The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (PYY).\n\nThe measurements of Plasma PYY concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).\n\nAll analyses will be performed according to the manufacturer's protocol and instructions."}, {'measure': 'Appetite related hormone [ Acylated Ghrelin]', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': "The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on hunger hormone (Acylated Ghrelin).\n\nThe measurements of Plasma Acylated Ghrelin concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).\n\nAll analyses will be performed according to the manufacturer's protocol and instructions."}, {'measure': 'Cardiometabolic risk factor (Triglycerides)', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': 'Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).'}, {'measure': 'Cardiometabolic risk factor (Insulin)', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': 'ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).'}, {'measure': 'Cardiometabolic risk factor (Glucose)', 'timeFrame': '4 weeks, 12 weeks, and 20 weeks', 'description': 'Glucose levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).\n\nHOMA-IR values will be calculated using the equation developed by Matthews and colleagues (Matthews, 1985).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Cardiometabolic risk factors', 'Fat mass', 'Fat free mass', 'Body composition', 'Muscle strength', 'LCn-3PUFA'], 'conditions': ['Obesity Associated Disorder']}, 'referencesModule': {'references': [{'pmid': '40671417', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* 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?\n* 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).\n\nThe 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).', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (male/female)\n* body mass index (BMI) of 25 - 39.9 kg/m2\n* Aged between 25 and 65 years\n* stable body weight for at least three months\n\nExclusion Criteria:\n\n* Smokers\n* Food allergy\n* On any dietary supplements or dietary regimes at the time of the study\n* Participants with systolic/diastolic \\<90/60 mmHg and \\>140/90 mmHg'}, 'identificationModule': {'nctId': 'NCT06001632', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'U Glasgow'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Krill oil capsules (LC n-3 PUFAs)', 'description': '4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.', 'interventionNames': ['Dietary Supplement: krill oil (SuperbaBoostTM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vegetable oil capsules', '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).', 'interventionNames': ['Dietary Supplement: 4g/day of mixed vegetable oil']}], 'interventions': [{'name': 'krill oil (SuperbaBoostTM)', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).', 'armGroupLabels': ['Krill oil capsules (LC n-3 PUFAs)']}, {'name': '4g/day of mixed vegetable oil', 'type': 'DIETARY_SUPPLEMENT', '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).', 'armGroupLabels': ['Vegetable oil capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G31 2ER', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University of Glasgow, New Lister Building', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Mansour Alblaji', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study will published in scientific journal upon finished'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow', 'investigatorFullName': 'Dr Dalia Malkova', 'investigatorAffiliation': 'University of Glasgow'}}}}