Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT06684834
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Carbohydrate Restriction in Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomised, three-arm parallel-group study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2036-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-09', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-11-09', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical Activity Energy Expenditure (kJ or kcal)', 'timeFrame': '1 week during baseline monitoring, and weeks 1 and 4 of the intervention', 'description': 'Assessed using combined heart rate and accelerometery wearable monitor (Actiheart™) in free-living conditions.'}, {'measure': 'Time Spent in Different Physical Activity Intensities (minutes)', 'timeFrame': '1 week during baseline monitoring, and weeks 1 and 4 of the intervention', 'description': 'Assessed using combined heart rate and accelerometery wearable monitor (Actiheart™) in free-living conditions'}, {'measure': 'Dietary Intake', 'timeFrame': '1 week during baseline monitoring, and weeks 1 and 4 of intervention', 'description': 'Dietary records manually kept by study participants'}, {'measure': 'Interstitial Glucose', 'timeFrame': '2 weeks during baseline monitoring, 2 weeks during weeks 3-4 of intervention', 'description': 'Continuous glucose records will be used to capture interstitial glucose before and during the intervention'}, {'measure': 'Sleep Quality', 'timeFrame': 'Pre and post intervention (10 weeks)', 'description': 'Self-reported sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI) questionnaire, consisting of 9 questions. Seven component scores are derived, scored from 0 (no difficulty) to 3 (severe difficulty)'}, {'measure': 'Diet Satisfaction', 'timeFrame': 'Pre and post intervention (10 weeks)', 'description': "Diet satisfaction will be assessed via the 28-item Diet Satisfaction Questionnaire (28-DSQ), scored on a five-point Likert scale with 1 being 'Disagree Strongly' and 5 being 'Agree Strongly'"}, {'measure': 'Engagement with Mobile Application', 'timeFrame': '4 weeks post intervention', 'description': 'Data on number of sessions, session length, session interval and session frequency will be obtained through the Salus Metabolism mobile health application'}, {'measure': 'Usability of Mobile Application', 'timeFrame': '4 weeks post intervention', 'description': "Assessed via the mHealth App Usability Questionnaire, consisting of 16 statements scored on a seven-point Likert scale with 1 being 'Disagree' and 7 being 'Agree'"}, {'measure': 'Subjective App Usability and Engagement', 'timeFrame': '4 weeks post intervention', 'description': 'Participants will be asked to provide feedback on the Salus Metabolism mHealth application through a semi-structured interview. Thematic analysis will be used to analyse interview data.'}], 'primaryOutcomes': [{'measure': 'Post Prandial Triglyceride Area Under the Curve (AUC)', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Plasma triglyceride concentrations assessed postprandially for 5 hours after a mixed meal test'}], 'secondaryOutcomes': [{'measure': 'Fat Mass', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Measured in kilogrammes using Dual Energy X-ray Absorptiometry'}, {'measure': 'Lean Body Mass', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Measured in kilogrammes using Dual Energy X-ray Absorptiometry'}, {'measure': 'Fasting and Post Prandial Glucose Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Plasma glucose concentrations assessed after an overnight fast, postprandially for 5 hours after a mixed meal test'}, {'measure': 'Fasting and Post Prandial Insulin Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Plasma insulin concentrations assessed after an overnight fast, postprandially for 5 hours after a mixed meal test'}, {'measure': 'Fasting and Post Prandial NEFA Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Plasma NEFA concentrations assessed after an overnight fast, postprandially for 5 hours after a mixed meal test'}, {'measure': 'Fasting Triglyceride Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Plasma triglyceride concentrations assessed after an overnight fast'}, {'measure': 'Fasting Total Cholesterol Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Assessed after an overnight fast'}, {'measure': 'Fasting LDL-C Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Assessed after an overnight fast'}, {'measure': 'Fasting HDL-C Concentration', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Assessed after an overnight fast'}, {'measure': 'Substrate Oxidation', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Carbohydrate and fat oxidation rates will be measured using indirect calorimetry at rest and every hour postprandially'}, {'measure': 'Adipose Tissue Gene Expression', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Expression of several genes related to energy metabolism in adipose biopsies using real-time polymerase chain reaction (RT-PCR)'}, {'measure': 'Adipose Tissue Protein Expression', 'timeFrame': 'Pre and post intervention (4 weeks)', 'description': 'Expression of several proteins related to energy metabolism in adipose biopsies using Western blot'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carbohydrate restriction', 'carbohydrate timing', 'intermittent carbohydrate restriction', 'intermittent energy restriction', 'evening carbohydrate restriction', 'carbohydrate periodisation'], 'conditions': ['Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'Metabolic conditions, such as heart disease, type 2 diabetes, and metabolic syndrome, are among the leading causes of disability and mortality worldwide. Identifying innovative lifestyle strategies to reduce metabolic risk remains a public health priority. Further research is essential to understand how low carbohydrate intake influences human metabolism and how intermittent carbohydrate restriction impacts weight loss and metabolic health markers.\n\nThis study will investigate two interventions that restrict dietary carbohydrate intake on different schedules, examining their effects on metabolic health and energy balance in adults with abdominal overweight or obesity. The physiological mechanisms potentially underlying these effects will be explored by measuring a range of lifestyle and metabolic health parameters in both free-living and laboratory settings. A digital behaviour-change intervention will be incorporated after the dietary intervention to assess whether any metabolic effects can be sustained over time.\n\nThe study employs a three-arm parallel-group design consisting of a two-week lifestyle monitoring phase, a four-week dietary intervention, and a four-week digital intervention, with four laboratory visits throughout each phase. During the dietary intervention, participants will be allocated to one of three groups: (i) carbohydrate restriction (\\<8% of energy intake) on two consecutive days per week, (ii) carbohydrate restriction after 4 pm each day, or (iii) no dietary changes.\n\nDietary intake, physical activity, and glucose levels will be monitored through wearable devices in free-living conditions. The digital intervention will use a mobile health application that provides individualised lifestyle recommendations and education based on data collected in free-living conditions. Laboratory-based measures will include anthropometry, body composition scans, indirect calorimetry, blood pressure monitoring, fat biopsies, and postprandial sampling of blood and expired air.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Waist circumference of ≥94 cm (37 inches) if male and ≥80 cm (31.5 inches) if female, or BMI above 25 kg/m2\n2. Fat mass index (FMI) of \\>6 kg/m2 for males, and \\>9 kg/m2 for females\n3. Aged between 18-65 years\n4. Has maintained a stable weight in the last three months (\\<3% change in body mass)\n5. Keeps track of menstrual cycle regularity or oral contraceptive use (females only)\n\nExclusion Criteria:\n\n1. Has a body weight of ≥120kg\n2. Plans to undertake other lifestyle modifications during the study to manage weight (e.g. changes in dietary intake or activity levels)\n3. Current or previous eating disorder\n4. Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)\n5. Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications)\n6. Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating\n7. Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit\n8. Insufficient mental capacity or language skills to independently understand and follow the study protocol\n9. Dietary restrictions to ingredients in test meals (e.g. gluten and lactose)\n10. Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)\n11. Any condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment'}, 'identificationModule': {'nctId': 'NCT06684834', 'briefTitle': 'Intermittent Carbohydrate Restriction in Cardiometabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'The Effects of Intermittent Carbohydrate Restriction on Metabolic Health and Energy Balance in Adults with Abdominal Overweight and Obesity', 'orgStudyIdInfo': {'id': '323721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5:2 carbohydrate restriction (5:2CR)', 'description': 'Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.', 'interventionNames': ['Other: 5:2 carbohydrate restriction']}, {'type': 'EXPERIMENTAL', 'label': 'Early time-restricted carbohydrate intake (eTRC)', 'description': 'Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.', 'interventionNames': ['Other: Early time-restricted carbohydrate intake']}, {'type': 'NO_INTERVENTION', 'label': 'Lifestyle maintenance (control)', 'description': 'Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.'}], 'interventions': [{'name': '5:2 carbohydrate restriction', 'type': 'OTHER', 'description': 'Carbohydrate ingestion restricted to \\<8% of energy intake on 2 self-selected consecutive days each week over 28-30 days. Ad libitum dietary amount, type and pattern followed on the remaining 5 days each week.', 'armGroupLabels': ['5:2 carbohydrate restriction (5:2CR)']}, {'name': 'Early time-restricted carbohydrate intake', 'type': 'OTHER', 'description': 'Carbohydrate intake restricted to \\<8% of energy intake after 4pm each day for 28 days. Ad libitum dietary amount, type and pattern followed before 4pm.', 'armGroupLabels': ['Early time-restricted carbohydrate intake (eTRC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA2 7AY', 'city': 'Bath', 'state': 'Somerset', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Guoda Karoblyte', 'role': 'CONTACT', 'email': 'gk678@bath.ac.uk', 'phone': '+44 (0) 1225 386478'}], 'facility': 'University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}], 'centralContacts': [{'name': 'Guoda Karoblyte', 'role': 'CONTACT', 'email': 'gk678@bath.ac.uk', 'phone': '+44 (0) 1225 386478'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guoda Karoblyte', 'investigatorAffiliation': 'University of Bath'}}}}