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

Abdominal Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194504
• Other study ID #: NL44614.081.13
• 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

• Abdominal Obesity
• Liver Fat
• Obesity, Abdominal

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