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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956356
• Other study ID #: SATIOSTAT acute effects
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Control treatment + oral glucose
Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load
• SATIOSTAT treatment + oral glucose
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load
• 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)
• 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)

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA	measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits	changes from baseline to three hours after treatment
Secondary	Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test	measured with oral glucose tolerance test	changes from baseline to three hours after treatment
Secondary	Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test	measured by 13C-sodium-acetate breath test	changes from baseline to four hours after treatment
Secondary	Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales	measured by visual analogue scales	changes from baseline to three hours after treatment
Secondary	Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal	calorie intake from a test meal will be assessed	changes from baseline to two hours after treatment