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

NCT02194504 | Completed

• 1 other identifier: NL44614.081.13
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Abdominal Obesity; Liver Fat

Keywords

Metabolic health; Phenotyping; Abdominal obesity; Abdominal adiposity; Liver fat; Belly fat

Outcome Measures

Primary Outcomes (12)

• 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)

  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

Secondary Outcomes (1)

• Satiety and wellbeing before and after mixed meal challenge

  Baseline and after 12-wk intervention

Study Arms (3)

No dietary advice

NO INTERVENTION

No dietary intervention

Dietary advice, Targeted

EXPERIMENTAL

12-wk dietary advice

Other: Dietary advice, Targeted

Dietary advice, Western

EXPERIMENTAL

12-wk dietary advice

Other: Dietary advice, Western

Interventions

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)

Dietary advice, Western

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)

Dietary advice, Targeted

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Wageningen University: lead

Related Publications (3)

• 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: 41034990 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.

  PMID: 38401691 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.

  PMID: 35102369 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Fatty Liver

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• L Afman, PhD

  Wageningen University. Department Human Nutrition. Nutrition, Metabolism & Genomics Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2015-04