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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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ClinicalTrials.gov Identifier: NCT02956369
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Control Dietary Supplement: SATIOSTAT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : May 6, 2019
Actual Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
Dietary Supplement: Control
Control granulates (maize starch and long-chain fatty acids) with powder
Other Name: The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.

Active Comparator: 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.
Dietary Supplement: SATIOSTAT
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder
Other Name: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.




Primary Outcome Measures :
  1. Effect of chronic SATIOSTAT intake on total body weight [ Time Frame: change from baseline to 6 weeks after SATIOSTAT intake ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956369


Locations
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Switzerland
St Claraspital
Basel, Switzerland, 4016
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Christoph Beglinger, MD St. Claraspital klinische Forschungsabteilung

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02956369     History of Changes
Other Study ID Numbers: SATIOSTAT chronic effects
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms