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

University Hospital Basel

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Control treatment + oral glucose; Dietary Supplement: SATIOSTAT treatment + meal intake; Dietary Supplement: Control treatment + meal intake; Dietary Supplement: SATIOSTAT treatment + oral glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT02956356

SATIOSTAT acute effects

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 4 patient groups, including a placebo group

Control treatment + oral glucose

Placebo Comparator group

Description:

Control treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates)

Treatment:

Dietary Supplement: Control treatment + oral glucose

SATIOSTAT treatment + oral glucose

Active Comparator group

Description:

SATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates)

Treatment:

Dietary Supplement: SATIOSTAT treatment + oral glucose

Control treatment + meal intake

Placebo Comparator group

Description:

Control treatment as preload followed by a test meal

Treatment:

Dietary Supplement: Control treatment + meal intake

SATIOSTAT treatment + meal intake

Active Comparator group

Description:

SATIOSTAT treatment as preload followed by a test meal

Treatment:

Dietary Supplement: SATIOSTAT treatment + meal intake