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OpenTrials
Completed

NCT Number: NCT02956369

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Claraspital

Basel, 4016, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Dietary Supplement

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

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

SATIOSTAT

Dietary Supplement

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

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

Primary outcomes

  1. Effect of chronic SATIOSTAT intake on total body weight

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

Secondary outcomes

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

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    measured with oral glucose tolerance test

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

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    measured with metagenomic shotgun sequencing

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

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry

  4. Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    Assessment by use of the Gastrointestinal Symptoms Rating Scale (Svedlund et al)

  5. Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    Assessment by use of the short form (SF)-36 questionnaire

  6. Effect of chronic SATIOSTAT intake on plasma Glucagon-like Peptide (GLP-1) concentrations measured by ELISA

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits

  7. Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale

    Time frame: change from baseline to 6 weeks after SATIOSTAT intake

    measured by using visual analogue scales

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2016
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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