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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

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 18, 2014
Last Update Posted Date April 17, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Intrahepatic lipid accumulation (IHL) [ Time Frame: Baseline and after 12-wk intervention ]
    Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)
  • 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)
  • Adipose tissue gene expression before and 4h after a mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Micro-array/qPCR
  • Markers of liver health (plasma) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Liver enzymes
  • Cardio-metabolic risk factors (plasma) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Insulin, glucose, Tg
  • Inflammatory markers (plasma) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Cytokines
  • Markers of adipose tissue health (plasma) [ Time Frame: Baseline and after 12-wk intervention ]
    Adipokines
  • Markers of gut health (plasma) [ Time Frame: Baseline and after 12-wk intervention ]
    Gut hormones
  • Microbiota (faeces) [ Time Frame: Baseline and after 12-wk intervention ]
  • Urinary metabolites [ Time Frame: Baseline and after 12-wk intervention ]
  • PBMC gene expression profile [ Time Frame: Baseline and after 12-wk intervention ]
    Micro-array/qPCR
  • Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    PWA
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02194504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Satiety and wellbeing before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
Assessment by validated questionnaires
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Food-cue reactivity [ Time Frame: Baseline and after 12-wk intervention ]
    fMRI after visual and olfactory food cues
  • Food preferences [ Time Frame: Baseline and after 12-wk intervention ]
    Assessment by validated questionnaires
  • Satiety and wellbeing before and after mixed meal challenge [ Time Frame: Baseline and after 12-wk intervention ]
    Assessment by validated questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity
Official Title  ICMJE The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity
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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Abdominal Obesity
  • Liver Fat
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • No Intervention: No dietary advice
    No dietary intervention
  • Experimental: Dietary advice, Targeted
    12-wk dietary advice
    Intervention: Other: Dietary advice, Targeted
  • Experimental: Dietary advice, Western
    12-wk dietary advice
    Intervention: Other: Dietary advice, Western
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02194504
Other Study ID Numbers  ICMJE NL44614.081.13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: L Afman, PhD Wageningen University. Department Human Nutrition. Nutrition, Metabolism & Genomics Group
PRS Account Wageningen University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP