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

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ClinicalTrials.gov Identifier: NCT02194504
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Wageningen University

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.


Condition or disease Intervention/treatment Phase
Abdominal Obesity Liver Fat Other: Dietary advice, Western Other: Dietary advice, Targeted Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
No Intervention: No dietary advice
No dietary intervention
Experimental: Dietary advice, Targeted
12-wk dietary advice
Other: Dietary advice, Targeted
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)

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




Primary Outcome Measures :
  1. Intrahepatic lipid accumulation (IHL) [ Time Frame: Baseline and after 12-wk intervention ]
    Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)

  2. Body fat distribution [ Time Frame: Baseline and after 12-wk intervention ]
    Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)

  3. Adipose tissue gene expression before and 4h after a mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Micro-array/qPCR

  4. Markers of liver health (plasma) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Liver enzymes

  5. Cardio-metabolic risk factors (plasma) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Insulin, glucose, Tg

  6. Inflammatory markers (plasma) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Cytokines

  7. Markers of adipose tissue health (plasma) [ Time Frame: Baseline and after 12-wk intervention ]
    Adipokines

  8. Markers of gut health (plasma) [ Time Frame: Baseline and after 12-wk intervention ]
    Gut hormones

  9. Microbiota (faeces) [ Time Frame: Baseline and after 12-wk intervention ]
  10. Urinary metabolites [ Time Frame: Baseline and after 12-wk intervention ]
  11. PBMC gene expression profile [ Time Frame: Baseline and after 12-wk intervention ]
    Micro-array/qPCR

  12. Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    PWA


Secondary Outcome Measures :
  1. Satiety and wellbeing before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Assessment by validated questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194504


Sponsors and Collaborators
Wageningen University
Investigators
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Principal Investigator: L Afman, PhD Wageningen University. Department Human Nutrition. Nutrition, Metabolism & Genomics Group

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02194504     History of Changes
Other Study ID Numbers: NL44614.081.13
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Wageningen University:
Metabolic health
Phenotyping
Abdominal obesity
Abdominal adiposity
Liver fat
Belly fat

Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms