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

NCT ID: NCT02956356

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-02-28

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: PLACEBO_COMPARATOR

Control treatment + oral glucose

Intervention Type: DIETARY_SUPPLEMENT

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

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)

Group Type: ACTIVE_COMPARATOR

SATIOSTAT treatment + oral glucose

Intervention Type: DIETARY_SUPPLEMENT

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

Control treatment + meal intake

Control treatment as preload followed by a test meal

Group Type: PLACEBO_COMPARATOR

Control treatment + meal intake

Intervention Type: 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)

SATIOSTAT treatment + meal intake

SATIOSTAT treatment as preload followed by a test meal

Group Type: ACTIVE_COMPARATOR

SATIOSTAT treatment + meal intake

Intervention Type: 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)

Interventions

Control treatment + oral glucose

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

Intervention Type: DIETARY_SUPPLEMENT

SATIOSTAT treatment + oral glucose

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

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.; The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.; The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.; The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Beglinger, MD

Role: STUDY_CHAIR

St. Claraspital klinische Forschungsabteilung

Locations

St Claraspital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

SATIOSTAT acute effects

Identifier Type: -

Identifier Source: org_study_id