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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956369
• Other study ID #: SATIOSTAT chronic effects
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: May 6, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Control
Control granulates (maize starch and long-chain fatty acids) with powder
• SATIOSTAT
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of chronic SATIOSTAT intake on total body weight		change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test	measured with oral glucose tolerance test	change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing	measured with metagenomic shotgun sequencing	change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces	Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry	change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire	Assessment by use of the Gastrointestinal Symptoms Rating Scale (Svedlund et al)	change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire	Assessment by use of the short form (SF)-36 questionnaire	change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on plasma Glucagon-like Peptide (GLP-1) concentrations measured by ELISA	measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits	change from baseline to 6 weeks after SATIOSTAT intake
Secondary	Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale	measured by using visual analogue scales	change from baseline to 6 weeks after SATIOSTAT intake