Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
NCT02956369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-08-14
Summary
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Control
Control granulates (maize starch and long-chain fatty acids) with powder
- DIETARY_SUPPLEMENT
-
SATIOSTAT
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder
Sponsors & Collaborators
-
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Christoph Beglinger, MD · St. Claraspital klinische Forschungsabteilung
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-10-16
- Primary Completion
- 2019-05-06
- Completion
- 2019-05-06
Countries
- Switzerland
Study Locations
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