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Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake

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ClinicalTrials.gov Identifier: NCT02956356
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : August 8, 2018
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.

Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and are then presented a test meal. Total calorie intake is measured as well as subjective feelings of satiation. In addition satiation hormones are measured.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Control treatment + oral glucose Dietary Supplement: SATIOSTAT treatment + oral glucose Dietary Supplement: Control treatment + meal intake Dietary Supplement: SATIOSTAT treatment + meal intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
Study Start Date : October 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Placebo Comparator: Control treatment + oral glucose
Control treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates)
Dietary Supplement: Control treatment + oral glucose
Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load
Other Name: The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.

Active Comparator: SATIOSTAT treatment + oral glucose
SATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates)
Dietary Supplement: SATIOSTAT treatment + oral glucose
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load
Other Name: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.

Placebo Comparator: Control treatment + meal intake
Control treatment as preload followed by a test meal
Dietary Supplement: Control treatment + meal intake
Control granulates (maize starch and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
Other Name: The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.

Active Comparator: SATIOSTAT treatment + meal intake
SATIOSTAT treatment as preload followed by a test meal
Dietary Supplement: SATIOSTAT treatment + meal intake
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
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. Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA [ Time Frame: changes from baseline to three hours after treatment ]
    measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits


Secondary Outcome Measures :
  1. Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test [ Time Frame: changes from baseline to three hours after treatment ]
    measured with oral glucose tolerance test

  2. Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test [ Time Frame: changes from baseline to four hours after treatment ]
    measured by 13C-sodium-acetate breath test

  3. Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales [ Time Frame: changes from baseline to three hours after treatment ]
    measured by visual analogue scales

  4. Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal [ Time Frame: changes from baseline to two hours after treatment ]
    calorie intake from a test meal will be assessed



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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): NCT02956356


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: NCT02956356     History of Changes
Other Study ID Numbers: SATIOSTAT acute effects
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs