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Completed

NCT Number: NCT02956356

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

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.

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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 treatment + oral glucose

Dietary Supplement

Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load

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

SATIOSTAT treatment + oral glucose

Dietary Supplement

SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load

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

Control treatment + meal intake

Dietary Supplement

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

SATIOSTAT treatment + meal intake

Dietary Supplement

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 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. 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2016
Registry last updated
Aug 8, 2018

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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