Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-18 @ 12:00 PM
Study NCT ID:
NCT03145350
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2017-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'PI,and research assistants undertaking measurements will be blinded to the dietary intervention the participant is undertaking.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomised crossover with washout period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver fat content', 'timeFrame': 'Before, and within 7 days after completion of each dietary intervention', 'description': 'Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).'}], 'secondaryOutcomes': [{'measure': 'Change in hepatic fatty acid partitioning', 'timeFrame': 'Within 7 days after completion of each dietary intervention', 'description': 'Investigators will utilise stable isotope tracer methodology to measure the contribution of newly synthesised fatty acids and dietary fatty acids to triglyceride production and oxidation pathways in the liver after each of the 4 week intervention diets.'}, {'measure': 'Change in plasma metabolite concentrations', 'timeFrame': 'Before, and within 7 days after completion of each dietary intervention.', 'description': 'Circulating concentrations of glucose, insulin, non-esterified fatty acids, and triglycerides will be measured biochemically using a clinical analyser after each of the 4 week intervention diets.'}, {'measure': 'Change in whole-body fatty acid oxidation', 'timeFrame': 'Within 7 days after completion of each dietary intervention', 'description': 'Investigators will utilise stable isotope tracer methodology to measure whole-body dietary fatty acid oxidation after each of the 4 week intervention diets.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NAFLD', 'Fat intake', 'Sugar intake'], 'conditions': ['Fat; Liver', 'NAFLD']}, 'referencesModule': {'references': [{'pmid': '32165444', 'type': 'DERIVED', 'citation': 'Parry SA, Rosqvist F, Mozes FE, Cornfield T, Hutchinson M, Piche ME, Hulsmeier AJ, Hornemann T, Dyson P, Hodson L. Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars. Diabetes Care. 2020 May;43(5):1134-1141. doi: 10.2337/dc19-2331. Epub 2020 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world. It is currently unclear why fat starts to accumulate in the liver, although both the amount and type of food consumed have been implicated. The majority of studies that have investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess calories, which are known to increase liver fat. The effect of specific dietary components, when consumed as part of a diet not containing excess calories, on liver fat accumulation remains unclear.', 'detailedDescription': 'This research aims to investigate the role excessive consumption of specific macronutrients may play in the development of NAFLD. This will be achieved by subjecting participants to two specific dietary interventions (high-fat, low-carbohydrate and low-fat, high-carbohydrate) in a randomized, crossover research design. Liver fat content, and whole-body and hepatic fasting and postprandial lipid metabolism will be assessed before and after the specific dietary interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* BMI \\>25 \\<35kg/m2\n* No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism\n\nExclusion Criteria:\n\n* Age \\<30 or \\>65 years\n* Body mass index \\<25 or \\>35kg/m2\n* A blood haemoglobin \\<120mg/dL\n* Any metabolic condition or relevant drug therapy\n* People who do not tolerate fructose\n* Smoking\n* History of alcoholism or a greater than recommended alcohol intake\n* Pregnant or nursing mothers\n* Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months\n* History of severe claustrophobia\n* Presence of metallic implants, pacemaker\n* Haemorrhagic disorders\n* Anticoagulant treatment'}, 'identificationModule': {'nctId': 'NCT03145350', 'briefTitle': 'The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism', 'orgStudyIdInfo': {'id': 'Oxlip-2017-HFD/HSD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-fat, low-carbohydrate diet', 'description': 'Dietary intervention: Participants will consume a diet that is rich in saturated fat (20% total energy) and low in free sugars for 4 weeks. This diet will include commonly eaten foods such as butter, cheese, and fatty meat products. Total fat intake in this intervention will be 40-45% total energy.', 'interventionNames': ['Other: High-fat, low-carbohydrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-fat, high-carbohydrate diet', 'description': 'Dietary intervention: Participants will consume a diet that is low in saturated fat (\\~5% total energy) and rich in free sugars (20% total energy).The diet will include commonly eaten food and drink such as sugar sweetened beverages, confectionery (e.g. fruit gums) and table sugar.', 'interventionNames': ['Other: Low-fat, high-carbohydrate']}], 'interventions': [{'name': 'High-fat, low-carbohydrate', 'type': 'OTHER', 'description': 'Dietary intervention: 4 week', 'armGroupLabels': ['High-fat, low-carbohydrate diet']}, {'name': 'Low-fat, high-carbohydrate', 'type': 'OTHER', 'description': 'Dietary intervention: 4 week', 'armGroupLabels': ['Low-fat, high-carbohydrate diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Centre for Diabetes, Endocrinology and Metabolism', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Leanne Hodson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Following completion of the study, all individual data obtained from participants may potentially be shared with other researchers, both here in the United Kingdom and abroad, in appropriate circumstances. If data is to be shared with other researchers, it will be done so under fully anonymised conditions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}