Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT04019860
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-restricted Eating and High Intensity Interval Training Among Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Four-armed randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to high intensity interval training', 'timeFrame': 'Seven weeks', 'description': 'Number of completed exercise sessions out of those prescribed, in percentage'}, {'measure': 'Compliance to high intensity interval training', 'timeFrame': 'Seven weeks', 'description': 'Exercise intensity, heart rate in percentage of individual heart rate maximum'}, {'measure': 'Compliance to time-restricted eating', 'timeFrame': 'Seven weeks', 'description': 'Average daily eating window, in hours'}, {'measure': 'Adherence to time-restricted eating', 'timeFrame': 'Seven weeks', 'description': 'Average number of days where per week that daily eating window is 10 hours or less.'}, {'measure': 'Diet intake at baseline', 'timeFrame': '14 days at baseline (one week of habitual diet and one week after the intervention starts)', 'description': 'Online food diary'}, {'measure': 'Diet intake', 'timeFrame': 'The last 14 days of the intervention', 'description': 'Online food diary'}], 'primaryOutcomes': [{'measure': 'Glycaemic control', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Total area under the plasma glucose curve over two hours after a 75 g oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)'}, {'measure': 'Insulin levels after ingestion of glucose', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Total area under the serum insulin two hours after a 75 g oral glucose tolerance test'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min'}, {'measure': 'Body mass', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'In kg'}, {'measure': 'Body fat mass', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'In kg'}, {'measure': 'Body fat percentage', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'In percent of total body mass'}, {'measure': 'Fat-free body mass', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'In kg'}, {'measure': 'Fat-free body mass percentage', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'In percent of total body mass'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Average of three measurements, in mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Average of three measurements, in mmHg'}, {'measure': 'Resting heart rate', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Average of three measurements, in beats/min'}, {'measure': 'Cholesterol in blood', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Total fasting cholesterol in blood'}, {'measure': 'High density lipoprotein cholesterol in blood', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Fasting high density lipoprotein cholesterol i blood'}, {'measure': 'Low density lipoprotein cholesterol in blood', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Fasting low density lipoprotein cholesterol i blood'}, {'measure': 'Triglycerides in blood', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Fasting low density lipoprotein cholesterol i blood'}, {'measure': 'Average glucose levels', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Glycated haemoglobin (HbA1c)'}, {'measure': 'Insulinemia', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Fasting insulin in blood'}, {'measure': '24 hour glycaemic control', 'timeFrame': 'From baseline to the last 14 days of the intervention period', 'description': 'Average interstitial glucose levels during 24 h, area under the curve'}, {'measure': 'Postprandial glycaemic control', 'timeFrame': 'From baseline to the last 14 days of the intervention period', 'description': 'Average interstitial glucose levels 3 hours after the first meal of the day, area under the curve'}, {'measure': 'Nocturnal glycaemic control', 'timeFrame': 'From baseline to the last 14 days of the intervention period', 'description': 'Average interstitial glucose levels from 23:00 h to 06:00 h'}, {'measure': 'Self-reported physical activity', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'International Physical Activity Questionnaire'}, {'measure': 'Measured physical activity', 'timeFrame': 'From baseline to the last 14 days of the intervention period', 'description': 'Measure by Sensewear activity monitor'}, {'measure': 'Sleep', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Self-reported: Pittsburgh Sleep Quality Index'}, {'measure': 'Chronotype', 'timeFrame': 'From baseline to after 7 weeks intervention', 'description': 'Self-reported: Hornestberg Morningness Eveningness Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Diet', 'Overweight', 'Glycaemic control', 'Fitness', 'Body composition'], 'conditions': ['Obesity; Endocrine']}, 'referencesModule': {'references': [{'pmid': '39861348', 'type': 'DERIVED', 'citation': 'Haganes KL, Devlin BL, Orr RK, Moholdt T. Impact of Time-Restricted Eating and High-Intensity Exercise on Nutrient Intake in Women with Overweight/Obesity: Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2025 Jan 8;17(2):218. doi: 10.3390/nu17020218.'}, {'pmid': '36198292', 'type': 'DERIVED', 'citation': 'Haganes KL, Silva CP, Eyjolfsdottir SK, Steen S, Grindberg M, Lydersen S, Hawley JA, Moholdt T. Time-restricted eating and exercise training improve HbA1c and body composition in women with overweight/obesity: A randomized controlled trial. Cell Metab. 2022 Oct 4;34(10):1457-1471.e4. doi: 10.1016/j.cmet.2022.09.003.'}, {'pmid': '33550228', 'type': 'DERIVED', 'citation': 'Moholdt T, Silva CP, Lydersen S, Hawley JA. Isolated and combined effects of high-intensity interval training and time-restricted eating on glycaemic control in reproductive-aged women with overweight or obesity: study protocol for a four-armed randomised controlled trial. BMJ Open. 2021 Feb 5;11(2):e040020. doi: 10.1136/bmjopen-2020-040020.'}]}, 'descriptionModule': {'briefSummary': 'This project will determine the independent and combined effects of high intensity interval training and time-restricted eating on blood sugar regulation among women in reproductive-age who have overweight or obesity. The intervention period will be seven weeks. Before and after the intervention, blood sugar regulation, body composition and physical fitness will be measured and compared between groups who are doing either high intensity interval training, time-restricted eating, both high intensity interval training and time-restricted eating, or who are in a control group. Physical activity, sleep quality, continuous glucose monitoring, adherence to the interventions and hunger/satiety will also be measured.', 'detailedDescription': 'In a follow-up study, we will invite randomized participants to come in for new assessments of physical fitness, body composition and fasting blood samples, and they will be asked to complete questionnaires about adherence to the interventions two years after intervention-end. The first participants will come in to the laboratory for the two-year follow up in November 2021.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index ≥ 27 kg/cm2,\n* able to walk on a treadmill or ride a bike for at least 60 min.\n\nExclusion Criteria:\n\n* Pregnancy, lactation within 24 weeks of study commencement\n* known cardiovascular disease\n* type 1 or 2 diabetes\n* currently taking hypertension or glucose- or lipid-lowering medication\n* habitual eating window \\< 12 hours\n* performing high intensity training more than once a week\n* body mass variations \\> 4 kg three months prior to study commencement\n* shift work that includes night shifts.'}, 'identificationModule': {'nctId': 'NCT04019860', 'briefTitle': 'Time-restricted Eating and High Intensity Interval Training Among Women', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Isolated and Combined Effects of High Intensity Interval Training and Time Restricted Eating on Glycaemic Control in Reproductive-aged Women With Overweight or Obesity', 'orgStudyIdInfo': {'id': '2019/851'}, 'secondaryIdInfos': [{'id': '285171', 'type': 'OTHER', 'domain': 'Comittee for Medical and Health Research Ethics Mid Norway'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training', 'description': 'High intensity interval training for seven weeks. Three weekly, supervised training sessions.', 'interventionNames': ['Behavioral: High Intensity Interval Training']}, {'type': 'EXPERIMENTAL', 'label': 'Time-Restricted Eating', 'description': 'Time-restricted eating for seven weeks. Maximal daily eating window of 10 hours.', 'interventionNames': ['Behavioral: Time-Restricted Eating']}, {'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training & Time-Restricted Eating', 'interventionNames': ['Behavioral: High Intensity Interval Training', 'Behavioral: Time-Restricted Eating']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Will be given information about the recommended level of physical activity for health benefits and a healthy diet.'}], 'interventions': [{'name': 'High Intensity Interval Training', 'type': 'BEHAVIORAL', 'description': 'Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.', 'armGroupLabels': ['High Intensity Interval Training', 'High Intensity Interval Training & Time-Restricted Eating']}, {'name': 'Time-Restricted Eating', 'type': 'BEHAVIORAL', 'description': 'Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.', 'armGroupLabels': ['High Intensity Interval Training & Time-Restricted Eating', 'Time-Restricted Eating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of circulation and medical imaging , NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øystein T Risa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Trine T Moholdt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Australian Catholic University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}