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

NCT ID: NCT02956369

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2019-05-06

Brief 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

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Control granulates (maize starch and long-chain fatty acids) with powder

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.

Group Type: ACTIVE_COMPARATOR

SATIOSTAT

Intervention Type: DIETARY_SUPPLEMENT

SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder

Interventions

Control

Control granulates (maize starch and long-chain fatty acids) with powder

Intervention Type: DIETARY_SUPPLEMENT

SATIOSTAT

SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.; The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Beglinger, MD

Role: STUDY_CHAIR

St. Claraspital klinische Forschungsabteilung

Locations

St Claraspital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

SATIOSTAT chronic effects

Identifier Type: -

Identifier Source: org_study_id