The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Body fat distribution
研究概览
简要总结
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.
详细描述
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:
- 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30% caloric restriction and a Western style nutrient composition
- 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
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-70y at the time of recruitment
- •BMI >27kg/m2 or waist circumference >102cm (males) or >88cm (females)
排除标准
- •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
研究组 & 干预措施
No dietary advice
No dietary intervention
Dietary advice, Targeted
12-wk dietary advice
干预措施: Dietary advice, Targeted (Other)
Dietary advice, Western
12-wk dietary advice
干预措施: Dietary advice, Western (Other)
结局指标
主要结局
Body fat distribution
时间窗: Baseline and after 12-wk intervention
Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)
Markers of gut health (plasma)
时间窗: Baseline and after 12-wk intervention
Gut hormones
Microbiota (faeces)
时间窗: Baseline and after 12-wk intervention
PBMC gene expression profile
时间窗: Baseline and after 12-wk intervention
Micro-array/qPCR
Intrahepatic lipid accumulation (IHL)
时间窗: Baseline and after 12-wk intervention
Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)
Cardio-metabolic risk factors (plasma) before and after mixed meal challenge
时间窗: Baseline and after 12-wk intervention
Insulin, glucose, Tg
Inflammatory markers (plasma) before and after mixed meal challenge
时间窗: Baseline and after 12-wk intervention
Cytokines
Markers of adipose tissue health (plasma)
时间窗: Baseline and after 12-wk intervention
Adipokines
Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge
时间窗: Baseline and after 12-wk intervention
PWA
Adipose tissue gene expression before and 4h after a mixed meal challenge
时间窗: Baseline and after 12-wk intervention
Micro-array/qPCR
Markers of liver health (plasma) before and after mixed meal challenge
时间窗: Baseline and after 12-wk intervention
Liver enzymes
Urinary metabolites
时间窗: Baseline and after 12-wk intervention
次要结局
- Satiety and wellbeing before and after mixed meal challenge(Baseline and after 12-wk intervention)