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Abdominal ObesityNCT02194504

The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity

A study testing Dietary advice, Western and Dietary advice, Targeted in people with Abdominal Obesity and Liver Fat, run by Wageningen University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Abdominal Obesity, Liver Fat
What is being tested?
Dietary advice, Western and Dietary advice, Targeted
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
Sep 2014to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 40-70y at the time of recruitment
  • BMI >27kg/m2 or waist circumference >102cm (males) or >88cm (females)

Who cannot join

  • Diabetic (normoglycemic according to WHO criteria (OGTT, fasting blood glucose< 7 mmol/L, after 2 hr <11.1 mmol/L)
  • Daily intake of alcohol of >30g (men) or >20g (women)
  • Tobacco smoker
  • Abuse of drugs
  • 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.)
  • Diagnosed with any long-term medical condition (i.e. cardiovascular disease, gastrointestinal disease, renal dysfunction)
Show all 10Show fewer
  • Use of medications known to interfere with glucose or lipid homeostasis (i.e. corticosteroids)
  • Allergic to fish oil or unwilling to consume fish oil supplements
  • Unwilling to comply with dietary guidelines
  • Restricted to a vegetarian dietary regime

About this study

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.

Read the detailed description

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:

  1. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30% caloric restriction and a Western style nutrient composition
  2. 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
  3. 30 subjects, control group, no nutritional intervention (optional: dietary advice at the end of the study period)

Measurements on metabolic health will be conducted at baseline and after 12-wk intervention and include:

  • MR imaging for determining body fat distribution
  • MR spectroscopy for quantification of liver fat
  • Blood sampling (plasma and PBMCs) before and several timepoints after mixed meal challenge
  • Adipose tissue sampling before and after mixed meal challenge
  • Vascular measurements before and after mixed meal challenge
  • Urine and feces sampling

Study population: Males and females, 40-70 yrs old, BMI > 27 kg/m2

Being tested
Dietary advice, Western, Dietary advice, Targeted
Keywords
Metabolic health, Phenotyping, Abdominal obesity, Abdominal adiposity, Liver fat, Belly fat
Medical subject headings
Obesity, Abdominal, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary advice, WesternOther

    Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)

  • Dietary advice, TargetedOther

    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)

Study groups in NCT02194504
Study groupRoleWhat they receive
No dietary adviceNo interventionNo dietary intervention
Dietary advice, TargetedExperimental12-wk dietary advice
Receives: Other: Dietary advice, Targeted
Dietary advice, WesternExperimental12-wk dietary advice
Receives: Other: Dietary advice, Western

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intrahepatic lipid accumulation (IHL)

    Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)

    Measured: Baseline and after 12-wk intervention

  2. Body fat distribution

    Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)

    Measured: Baseline and after 12-wk intervention

  3. Adipose tissue gene expression before and 4h after a mixed meal challenge

    Micro-array/qPCR

    Measured: Baseline and after 12-wk intervention

  4. Markers of liver health (plasma) before and after mixed meal challenge

    Liver enzymes

    Measured: Baseline and after 12-wk intervention

  5. Cardio-metabolic risk factors (plasma) before and after mixed meal challenge

    Insulin, glucose, Tg

    Measured: Baseline and after 12-wk intervention

  6. Inflammatory markers (plasma) before and after mixed meal challenge

    Cytokines

    Measured: Baseline and after 12-wk intervention

  7. Markers of adipose tissue health (plasma)

    Adipokines

    Measured: Baseline and after 12-wk intervention

  8. Markers of gut health (plasma)

    Gut hormones

    Measured: Baseline and after 12-wk intervention

  9. Microbiota (faeces)

    Measured: Baseline and after 12-wk intervention

  10. Urinary metabolites

    Measured: Baseline and after 12-wk intervention

  11. PBMC gene expression profile

    Micro-array/qPCR

    Measured: Baseline and after 12-wk intervention

  12. Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge

    PWA

    Measured: Baseline and after 12-wk intervention

Secondary outcomes (1)

  1. Satiety and wellbeing before and after mixed meal challenge

    Assessment by validated questionnaires

    Measured: Baseline and after 12-wk intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194504
Sponsor's protocol ID
NL44614.081.13
Status last verified
Apr 2015
First submitted
16 Jul 2014
Last updated
17 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 41935270

  • 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.

    PubMed 41034990

  • 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.

    PubMed 38401691

  • 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.

    PubMed 35102369

Questions about this trial

What is this clinical trial studying?

A study testing Dietary advice, Western and Dietary advice, Targeted in people with Abdominal Obesity and Liver Fat, run by Wageningen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrahepatic lipid accumulation (IHL) (time frame: Baseline and after 12-wk intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02194504, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.

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