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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.
The 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.
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.
Objective: 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.
Study design and intervention: Randomized, parallel design consisting of three groups:
Measurements on metabolic health will be conducted at baseline and after 12-wk intervention and include:
Study population: Males and females, 40-70 yrs old, BMI > 27 kg/m2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No dietary advice | No Intervention | No dietary intervention | |
| Dietary advice, Targeted | Experimental | 12-wk dietary advice |
|
| Dietary advice, Western | Experimental | 12-wk dietary advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary advice, Western | Other | Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy) |
| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatic lipid accumulation (IHL) | Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy) | Baseline and after 12-wk intervention |
| Body fat distribution | Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging) | Baseline and after 12-wk intervention |
| Adipose tissue gene expression before and 4h after a mixed meal challenge | Micro-array/qPCR | Baseline and after 12-wk intervention |
| Markers of liver health (plasma) before and after mixed meal challenge | Liver enzymes | Baseline and after 12-wk intervention |
| Cardio-metabolic risk factors (plasma) before and after mixed meal challenge | Insulin, glucose, Tg | Baseline and after 12-wk intervention |
| Inflammatory markers (plasma) before and after mixed meal challenge | Cytokines | Baseline and after 12-wk intervention |
| Markers of adipose tissue health (plasma) | Adipokines | Baseline and after 12-wk intervention |
| Markers of gut health (plasma) |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety and wellbeing before and after mixed meal challenge | Assessment by validated questionnaires | Baseline and after 12-wk intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L Afman, PhD | Wageningen University. Department Human Nutrition. Nutrition, Metabolism & Genomics Group | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41935270 | Derived | Fang Y, de Mutsert R, Gijbels A, Deng K, Lamb H, Rosendaal FR, Mook-Kanamori DO, van Dijk KW, Afman LA, Li-Gao R. The association between liver fat content and plasma metabolite profiles in fasting and postprandial states: an integration of a cohort study and a randomized controlled trial. Cardiovasc Diabetol. 2026 Apr 4;25(1):119. doi: 10.1186/s12933-026-03158-4. | |
| 41034990 |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Dietary advice, Targeted | Other | 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) |
|
Gut hormones
| Baseline and after 12-wk intervention |
| Microbiota (faeces) | Baseline and after 12-wk intervention |
| Urinary metabolites | Baseline and after 12-wk intervention |
| PBMC gene expression profile | Micro-array/qPCR | Baseline and after 12-wk intervention |
| Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge | PWA | Baseline and after 12-wk intervention |
| 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. |
| 38401691 | Derived | 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. |
| 35102369 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |