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

NCT02956369 | Completed

• 1 other identifier: SATIOSTAT chronic effects
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effect of chronic SATIOSTAT intake on total body weight

  change from baseline to 6 weeks after SATIOSTAT intake

Secondary Outcomes (7)

• Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test

  change from baseline to 6 weeks after SATIOSTAT intake

• Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing

  change from baseline to 6 weeks after SATIOSTAT intake

• Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces

  change from baseline to 6 weeks after SATIOSTAT intake

• Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire

  change from baseline to 6 weeks after SATIOSTAT intake

• Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire

  change from baseline to 6 weeks after SATIOSTAT intake

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Dietary Supplement: Control

SATIOSTAT

ACTIVE COMPARATOR

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.

Dietary Supplement: SATIOSTAT

Interventions

Control DIETARY_SUPPLEMENT

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

Also known as: The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.

Control

SATIOSTAT DIETARY_SUPPLEMENT

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

Also known as: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.

SATIOSTAT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St Claraspital

Basel, 4016, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

CD36 Antigens; Carbohydrates; Proteins

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein

Study Officials

• Christoph Beglinger, MD

  St. Claraspital klinische Forschungsabteilung

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 7, 2016
• Study Start: October 16, 2017
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

CH (1)