Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-31 @ 3:00 PM
Study NCT ID:
NCT04100356
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise and/or Diet on Health Related Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Diet and exercise, or diet only'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2014-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-26', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under curve (AUC) glucose', 'timeFrame': 'Change from baseline AUC glucose at 10 weeks', 'description': 'AUC glucose measured during an OGTT'}], 'secondaryOutcomes': [{'measure': 'Lipid profile', 'timeFrame': 'Change from Baseline lipids at 10 weeks', 'description': 'Measurements of total cholesterol, LDL, HDL, TG'}, {'measure': 'Body composition', 'timeFrame': 'Change from baseline values at 10 weeks', 'description': 'Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'Change from baseline values at 10 weeks', 'description': 'Measurement of peak oxygen uptake'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-carbohydrate-high-fat diet (LCHF)', 'Low-density-lipoprotein (LDL)', 'High-density-lipoprotein (HDL)', 'Triglycerides (TG)', 'Lipids', 'Glucose tolerance (GT)', 'Insulin resistance (IR)', 'Body composition', 'Weight'], 'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '36760521', 'type': 'DERIVED', 'citation': 'Valsdottir TD, Ovrebo B, Kornfeldt TM, Litleskare S, Johansen EI, Henriksen C, Jensen J. Effect of aerobic exercise and low-carbohydrate high-fat diet on glucose tolerance and android/gynoid fat in overweight/obese women: A randomized controlled trial. Front Physiol. 2023 Jan 24;14:1056296. doi: 10.3389/fphys.2023.1056296. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise.', 'detailedDescription': 'Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance.\n\nExercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. While exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.\n\nWe wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '33 Years', 'genderBased': True, 'genderDescription': 'Premenopausal', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Sedentary\n* Premenopausal\n* Caucasian\n* BMI 26.9 - 36.1\n* Age 33-4\n* Living close to, or in Oslo.\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast-feeding\n* Smoking or tobacco use\n* Previous medical history of cardio-vascular disease (CVD)\n* Previous medical history of diabetes\n* Previous medical history of endocrine disorder\n* Previous medical history of kidney disease\n* Use of lipid lowering medication\n* Use of diabetes medication'}, 'identificationModule': {'nctId': 'NCT04100356', 'briefTitle': 'The Effect of Exercise and/or Diet on Health Related Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Atlantis Medical University College'}, 'officialTitle': 'The Effect of Exercise and/or Diet Body Composition, Cardiorespiratory Fitness and Blood Parameters Related to Improved Health in Overweight Females.', 'orgStudyIdInfo': {'id': 'AMUC-NIH-LCHF-P3-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal diet', 'description': 'The group ingests normal diet, recommended by the health authorities', 'interventionNames': ['Other: Normal Diet']}, {'type': 'EXPERIMENTAL', 'label': 'LCHF diet', 'description': 'The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat', 'interventionNames': ['Other: LCHF Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Normal diet + exercise', 'description': 'The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week.', 'interventionNames': ['Other: Exercise', 'Other: Normal Diet']}, {'type': 'EXPERIMENTAL', 'label': 'LCHF diet + exercise', 'description': 'The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week.', 'interventionNames': ['Other: Exercise', 'Other: LCHF Diet']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Exercise program - indoor bicycle interval exercise, duration 60 min 3x week', 'armGroupLabels': ['LCHF diet + exercise', 'Normal diet + exercise']}, {'name': 'Normal Diet', 'type': 'OTHER', 'description': 'Normal diet recommended by the health authorities', 'armGroupLabels': ['Normal diet', 'Normal diet + exercise']}, {'name': 'LCHF Diet', 'type': 'OTHER', 'description': 'LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates', 'armGroupLabels': ['LCHF diet', 'LCHF diet + exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0863', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Norwegian School of Sports Sciences', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jørgen Jensen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian School of Sport Sciences, Section of Physical Performance'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantis Medical University College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian School of Sport Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}