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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02194504
Other study ID # NL44614.081.13
Secondary ID
Status Completed
Phase N/A
First received July 16, 2014
Last updated April 16, 2015
Start date September 2014
Est. completion date March 2015

Study information

Verified date April 2015
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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). 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Outcome

Type Measure Description Time frame Safety issue
Primary Intrahepatic lipid accumulation (IHL) Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy) Baseline and after 12-wk intervention No
Primary Body fat distribution Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging) Baseline and after 12-wk intervention No
Primary Adipose tissue gene expression before and 4h after a mixed meal challenge Micro-array/qPCR Baseline and after 12-wk intervention No
Primary Markers of liver health (plasma) before and after mixed meal challenge Liver enzymes Baseline and after 12-wk intervention No
Primary Cardio-metabolic risk factors (plasma) before and after mixed meal challenge Insulin, glucose, Tg Baseline and after 12-wk intervention No
Primary Inflammatory markers (plasma) before and after mixed meal challenge Cytokines Baseline and after 12-wk intervention No
Primary Markers of adipose tissue health (plasma) Adipokines Baseline and after 12-wk intervention No
Primary Markers of gut health (plasma) Gut hormones Baseline and after 12-wk intervention No
Primary Microbiota (faeces) Baseline and after 12-wk intervention No
Primary Urinary metabolites Baseline and after 12-wk intervention No
Primary PBMC gene expression profile Micro-array/qPCR Baseline and after 12-wk intervention No
Primary Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge PWA Baseline and after 12-wk intervention No
Secondary Satiety and wellbeing before and after mixed meal challenge Assessment by validated questionnaires Baseline and after 12-wk intervention No
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