Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.

University Hospital Basel

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: SATIOSTAT; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02956369

SATIOSTAT chronic effects

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obese volunteers (BMI > 30kg/m2)
• Otherwise healthy
• Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control

SATIOSTAT

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: SATIOSTAT