Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA
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.
Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and are then presented a test meal. Total calorie intake is measured as well as subjective feelings of satiation. In addition satiation hormones are measured.
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
- 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 treatment + oral glucose
Control treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates)
干预措施: Control treatment + oral glucose (Dietary Supplement)
SATIOSTAT treatment + oral glucose
SATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates)
干预措施: SATIOSTAT treatment + oral glucose (Dietary Supplement)
Control treatment + meal intake
Control treatment as preload followed by a test meal
干预措施: Control treatment + meal intake (Dietary Supplement)
SATIOSTAT treatment + meal intake
SATIOSTAT treatment as preload followed by a test meal
干预措施: SATIOSTAT treatment + meal intake (Dietary Supplement)
结局指标
主要结局
Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA
时间窗: changes from baseline to three hours after treatment
measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits
次要结局
- Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal(changes from baseline to two hours after treatment)
- Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test(changes from baseline to three hours after treatment)
- Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales(changes from baseline to three hours after treatment)
- Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test(changes from baseline to four hours after treatment)