Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-16 @ 6:44 AM
Study NCT ID:
NCT02194504
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2014-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2014-07-16', 'studyFirstSubmitQcDate': '2014-07-16', 'lastUpdatePostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intrahepatic lipid accumulation (IHL)', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)'}, {'measure': 'Body fat distribution', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)'}, {'measure': 'Adipose tissue gene expression before and 4h after a mixed meal challenge', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Micro-array/qPCR'}, {'measure': 'Markers of liver health (plasma) before and after mixed meal challenge', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Liver enzymes'}, {'measure': 'Cardio-metabolic risk factors (plasma) before and after mixed meal challenge', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Insulin, glucose, Tg'}, {'measure': 'Inflammatory markers (plasma) before and after mixed meal challenge', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Cytokines'}, {'measure': 'Markers of adipose tissue health (plasma)', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Adipokines'}, {'measure': 'Markers of gut health (plasma)', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Gut hormones'}, {'measure': 'Microbiota (faeces)', 'timeFrame': 'Baseline and after 12-wk intervention'}, {'measure': 'Urinary metabolites', 'timeFrame': 'Baseline and after 12-wk intervention'}, {'measure': 'PBMC gene expression profile', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Micro-array/qPCR'}, {'measure': 'Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'PWA'}], 'secondaryOutcomes': [{'measure': 'Satiety and wellbeing before and after mixed meal challenge', 'timeFrame': 'Baseline and after 12-wk intervention', 'description': 'Assessment by validated questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic health', 'Phenotyping', 'Abdominal obesity', 'Abdominal adiposity', 'Liver fat', 'Belly fat'], 'conditions': ['Abdominal Obesity', 'Liver Fat']}, 'referencesModule': {'references': [{'pmid': '41034990', 'type': 'DERIVED', 'citation': 'Fang Y, Hooiveld GJEJ, Afman LA. Mixed-meal challenge differentially modulates metabolic pathways in adipose tissue in healthy abdominally obese subjects with high versus low liver fat: a secondary analysis of a randomized clinical trial. Nutr Metab (Lond). 2025 Oct 1;22(1):112. doi: 10.1186/s12986-025-01010-2.'}, {'pmid': '38401691', 'type': 'DERIVED', 'citation': 'Wang Y, Balvers MGJ, Esser D, Schutte S, Vincken JP, Afman LA, Witkamp RF, Meijerink J. Nutrient composition of different energy-restricted diets determines plasma endocannabinoid profiles and adipose tissue DAGL-alpha expression; a 12-week randomized controlled trial in subjects with abdominal obesity. J Nutr Biochem. 2024 Jun;128:109605. doi: 10.1016/j.jnutbio.2024.109605. Epub 2024 Feb 23.'}, {'pmid': '35102369', 'type': 'DERIVED', 'citation': 'Schutte S, Esser D, Siebelink E, Michielsen CJR, Daanje M, Matualatupauw JC, Boshuizen HC, Mensink M, Afman LA; Wageningen Belly Fat Study team. Diverging metabolic effects of 2 energy-restricted diets differing in nutrient quality: a 12-week randomized controlled trial in subjects with abdominal obesity. Am J Clin Nutr. 2022 Jul 6;116(1):132-150. doi: 10.1093/ajcn/nqac025.'}]}, 'descriptionModule': {'briefSummary': 'In the Belly Fat study, the effects of two different caloric-restricted diets on metabolic health will be examined in male and female subjects with increased abdominal adiposity (BMI \\>27 kg/m2). Metabolic health is defined as health of the primary metabolic organs the liver, gut and the adipose tissue, examined in a static state as well as after the application of a challenge test.\n\nThe diets are equally caloric-restricted, but differ in nutrient composition. It is hypothesized that one of the two diets causes a larger improvement in organ health and reduction in liver fat.', 'detailedDescription': 'Rationale: It is known that in particular visceral fat (abdominal obesity) and fat deposition in non-adipose tissue such as the liver are important factors related to metabolic health, such as the degree of insulin resistance, dyslipidaemia and other well-established cardio-metabolic risk factors. The arise of pathological consequences of abdominal obesity are a result of a disturbance in the elegant interplay between metabolic organs, such as the liver, adipose tissue and gut. Several nutrients have demonstrated to exert positive or negative effects on the health and functioning of metabolic organs. A diet (whole dietary approach) can thus be a power tool to improve the health status of individuals with abdominal obesity by improving organ health.\n\nObjective: The primary objective of this study is to compare the effects of two different diets on the static metabolic health status as assessed by determination of organ health and, more specifically, of lipid accumulation in the liver. The application of a mixed meal challenge test will be used to gain insight in the dynamic metabolic health status. A secondary objective is to determine the reaction (brain activity) of individuals with abdominal obesity after visual and olfactory food-cues.\n\nStudy design and intervention: Randomized, parallel design consisting of three groups:\n\n1. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30% caloric restriction and a Western style nutrient composition\n2. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30% caloric restriction with a nutrient composition aimed at improving organ health and reducing liver fat\n3. 30 subjects, control group, no nutritional intervention (optional: dietary advice at the end of the study period)\n\nMeasurements on metabolic health will be conducted at baseline and after 12-wk intervention and include:\n\n* MR imaging for determining body fat distribution\n* MR spectroscopy for quantification of liver fat\n* Blood sampling (plasma and PBMCs) before and several timepoints after mixed meal challenge\n* Adipose tissue sampling before and after mixed meal challenge\n* Vascular measurements before and after mixed meal challenge\n* Urine and feces sampling\n\nStudy population: Males and females, 40-70 yrs old, BMI \\> 27 kg/m2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-70y at the time of recruitment\n* BMI \\>27kg/m2 or waist circumference \\>102cm (males) or \\>88cm (females)\n\nExclusion Criteria:\n\n* Diabetic (normoglycemic according to WHO criteria (OGTT, fasting blood glucose\\< 7 mmol/L, after 2 hr \\<11.1 mmol/L)\n* Daily intake of alcohol of \\>30g (men) or \\>20g (women)\n* Tobacco smoker\n* Abuse of drugs\n* Any medical conditions or (metal) devices interfering with or posing a risk for the participant in 1H-MRS/MRI scanning (e.g. claustrophobia, pace maker, surgical screws/pins, artificial joints or heart valves, etc.)\n* Diagnosed with any long-term medical condition (i.e. cardiovascular disease, gastrointestinal disease, renal dysfunction)\n* Use of medications known to interfere with glucose or lipid homeostasis (i.e. corticosteroids)\n* Allergic to fish oil or unwilling to consume fish oil supplements\n* Unwilling to comply with dietary guidelines\n* Restricted to a vegetarian dietary regime'}, 'identificationModule': {'nctId': 'NCT02194504', 'briefTitle': 'The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity', 'orgStudyIdInfo': {'id': 'NL44614.081.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No dietary advice', 'description': 'No dietary intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Dietary advice, Targeted', 'description': '12-wk dietary advice', 'interventionNames': ['Other: Dietary advice, Targeted']}, {'type': 'EXPERIMENTAL', 'label': 'Dietary advice, Western', 'description': '12-wk dietary advice', 'interventionNames': ['Other: Dietary advice, Western']}], 'interventions': [{'name': 'Dietary advice, Western', 'type': 'OTHER', 'description': 'Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)', 'armGroupLabels': ['Dietary advice, Western']}, {'name': 'Dietary advice, Targeted', 'type': 'OTHER', 'description': 'Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with nutrient composition aiming at an improvement in organ health and a reduction in liver fat (PUFA, fish, soy protein, whole grain)', 'armGroupLabels': ['Dietary advice, Targeted']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'L Afman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University. Department Human Nutrition. Nutrition, Metabolism & Genomics Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}