The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Changes in FIAF blood concentration
研究概览
简要总结
The objective of this study is to investigate whether intake of a diet with a high content of butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet. Further to examine whether high intake of inulin (a prebiotic) can increase the proportion of butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In addition, the correlation between FIAF blood concentrations and resting energy expenditure, blood lipid profile and gut microbiota composition will be investigated.
Furthermore, this study will investigate whether the source of FIAF can be determined. To this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal water samples will be carried out.
The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration of 3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the order of interventions. Before and after each intervention period, blood samples will be collected and the participants will have their resting metabolic rate measured. At the end of each intervention period, the participants will collect feces for 5 consecutive days. In addition, adipose tissue biopsies will be taken after each intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Age: 23-45
- •BMI: 25-32 kg/m2
- •Body fat percentage (BFP) > 25
排除标准
- •Chronic diseases (known diabetes, cardiovascular disease (CVD), Intestinal Bowel Disease and other chronic diseases likely to affect the results of the present study)
- •Milk allergy/lactose intolerance
- •Intolerance towards inulin
- •Fasting glucose ≥7.0 mmol/l or non-fasting glucose ≥ 11 mmol/l*
- •Use of antibiotics 2 months before commencement of study
- •Use of dietary supplements incl. multivitamins during run-in and the entire study period
- •Elite athletes (>10 hours of strenuous physical activity per week)
- •Use of prescription medicine which could affect the results of the present study, including systemic glucocorticoids
- •Use of lipid-lowering agents or medication with contraindications for a high fat diet
- •Blood pressure > 140/90 mmHg
- •Blood donation <1 month before study commencement and during study period
- •Simultaneous participation in other clinical studies
- •Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
研究组 & 干预措施
Inulin
The participants will be given all dietary items in their diet. In the inulin arm, approximately 15 grams of inulin will be included in the diet.
干预措施: Complete diet (Other)
Whole milk
The participants will be given all dietary items in their diet. In the whole milk arm, approximately 1 liter of whole milk will be included in the diet.
干预措施: Complete diet (Other)
Whole milk
The participants will be given all dietary items in their diet. In the whole milk arm, approximately 1 liter of whole milk will be included in the diet.
干预措施: Whole milk (Other)
Complete diet
The participants will be given all dietary items in their diet.
干预措施: Complete diet (Other)
Inulin
The participants will be given all dietary items in their diet. In the inulin arm, approximately 15 grams of inulin will be included in the diet.
干预措施: Inulin (Other)
结局指标
主要结局
Changes in FIAF blood concentration
时间窗: 21 days
次要结局
- Changes in FIAF mRNA/protein expressed in or secreted from human intestinal cell lines(21 days)
- Changes in resting energy expenditure/lipid oxidation(21 days)
- Changes in blood lipid profile including triglyceride, free fatty acid, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), glycerol, butyrate(21 days)
- Changes in microbiotic composition and characterization of gut microbiota, including metabolites(21 days)
- Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)(21 days)
- Changes in parameters involved in glucose metabolism(21 days)
- Changes in gene expression and protein concentration of genes/proteins related to obesity, lipid metabolism, adipocyte differentiation, hypoxia and FIAF signaling in adipose tissue(21 days)
- Changes in FIAF adipose tissue messenger ribonucleic acid (mRNA) levels(21 days)
研究者
Arne Astrup
Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports
University of Copenhagen