Dietary advice, Western
OtherDietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)
NCT Number: NCT02194504
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.
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Notify Me40 year–70 year
All sexes
Interventional
Not applicable
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:
Measurements on metabolic health will be conducted at baseline and after 12-wk intervention and include:
Study population: Males and females, 40-70 yrs old, BMI > 27 kg/m2
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)
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)
Time frame: Baseline and after 12-wk intervention
Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)
Time frame: Baseline and after 12-wk intervention
Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)
Time frame: Baseline and after 12-wk intervention
Micro-array/qPCR
Time frame: Baseline and after 12-wk intervention
Liver enzymes
Time frame: Baseline and after 12-wk intervention
Insulin, glucose, Tg
Time frame: Baseline and after 12-wk intervention
Cytokines
Time frame: Baseline and after 12-wk intervention
Adipokines
Time frame: Baseline and after 12-wk intervention
Gut hormones
Time frame: Baseline and after 12-wk intervention
Time frame: Baseline and after 12-wk intervention
Time frame: Baseline and after 12-wk intervention
Micro-array/qPCR
Time frame: Baseline and after 12-wk intervention
PWA
Time frame: Baseline and after 12-wk intervention
Assessment by validated questionnaires
Wageningen University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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