Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Effect of chronic SATIOSTAT intake on total body weight
研究概览
简要总结
SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid component (long-chain fatty acids). The goal of this combination is to achieve long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release of satiety-signals from intestinal cells, and consequently reducing appetite and lowering food intake in humans.
Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and as first course at dinner. Once before and after these 6 weeks the investigators will carry out an oral glucose challenge, measure satiation hormones and examine faeces (gut microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal symptoms and quality of life. The whole study will take approximately 8-10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese volunteers (BMI > 30kg/m2)
- •Otherwise healthy
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
排除标准
- •Food allergies, food intolerance
- •Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening
- •Chronic or clinically relevant acute infections
- •Clinically relevant abnormalities in chemical, haematological or any other laboratory parameters
- •Participation in drug trials within 2 months before start of the study
- •Neurological or psychiatric disease or drug or alcohol abuse, which would interfere with the subjects proper completion of the protocol assignment
- •Pregnancy: although no contraindication pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants of childbearing age not using safe contraception (oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) a urine pregnancy test is carried out upon screening.
- •Antibiotic therapy within the last 3 months before inclusion
- •Substance abuse, alcohol abuse
- •Inability to follow procedures due to psychological disorders, dementia or insufficient
- •Knowledge of project language (German).
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
研究组 & 干预措施
Control
10 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups. The control granulates consists of maize starch and long-chain fatty acids with powder.
干预措施: Control (Dietary Supplement)
SATIOSTAT
10 obese, non-diabetic candidates will ingest SATIOSTAT as meal replacement at lunch and as first course at dinner over a period of 6 weeks. The SATIOSTAT granulates consists of hydrocolloids (fibers) and long-chain fatty acids with powder.
干预措施: SATIOSTAT (Dietary Supplement)
结局指标
主要结局
Effect of chronic SATIOSTAT intake on total body weight
时间窗: change from baseline to 6 weeks after SATIOSTAT intake
次要结局
- Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing(change from baseline to 6 weeks after SATIOSTAT intake)
- Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire(change from baseline to 6 weeks after SATIOSTAT intake)
- Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale(change from baseline to 6 weeks after SATIOSTAT intake)
- Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test(change from baseline to 6 weeks after SATIOSTAT intake)
- Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces(change from baseline to 6 weeks after SATIOSTAT intake)
- Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire(change from baseline to 6 weeks after SATIOSTAT intake)
- Effect of chronic SATIOSTAT intake on plasma Glucagon-like Peptide (GLP-1) concentrations measured by ELISA(change from baseline to 6 weeks after SATIOSTAT intake)