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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Control
SATIOSTAT
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • St Claraspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

SATIOSTAT

Arm 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.

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.

Outcomes

Primary Outcome Measures

Effect of chronic SATIOSTAT intake on total body weight

Secondary Outcome Measures

Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test
measured with oral glucose tolerance test
Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing
measured with metagenomic shotgun sequencing
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
Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire
Assessment by use of the Gastrointestinal Symptoms Rating Scale (Svedlund et al)
Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire
Assessment by use of the short form (SF)-36 questionnaire
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
Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale
measured by using visual analogue scales

Full Information

First Posted
November 2, 2016
Last Updated
August 12, 2019
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02956369
Brief Title
Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Official Title
Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
May 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Arm Title
SATIOSTAT
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.
Intervention Description
Control granulates (maize starch and long-chain fatty acids) with powder
Intervention Type
Dietary Supplement
Intervention Name(s)
SATIOSTAT
Other Intervention Name(s)
The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.
Intervention Description
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder
Primary Outcome Measure Information:
Title
Effect of chronic SATIOSTAT intake on total body weight
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Secondary Outcome Measure Information:
Title
Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test
Description
measured with oral glucose tolerance test
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Title
Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing
Description
measured with metagenomic shotgun sequencing
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Title
Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces
Description
Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Title
Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire
Description
Assessment by use of the Gastrointestinal Symptoms Rating Scale (Svedlund et al)
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Title
Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire
Description
Assessment by use of the short form (SF)-36 questionnaire
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Title
Effect of chronic SATIOSTAT intake on plasma Glucagon-like Peptide (GLP-1) concentrations measured by ELISA
Description
measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake
Title
Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale
Description
measured by using visual analogue scales
Time Frame
change from baseline to 6 weeks after SATIOSTAT intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, MD
Organizational Affiliation
St. Claraspital klinische Forschungsabteilung
Official's Role
Study Chair
Facility Information:
Facility Name
St Claraspital
City
Basel
ZIP/Postal Code
4016
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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