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

NCT02956356 | Completed

• 1 other identifier: SATIOSTAT acute effects
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test

  changes from baseline to three hours after treatment

• Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test

  changes from baseline to four hours after treatment

• Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales

  changes from baseline to three hours after treatment

• Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal

  changes from baseline to two hours after treatment

Study Arms (4)

Control treatment + oral glucose

PLACEBO COMPARATOR

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

SATIOSTAT treatment + oral glucose

ACTIVE COMPARATOR

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

Control treatment + meal intake

PLACEBO COMPARATOR

Control treatment as preload followed by a test meal

Dietary Supplement: Control treatment + meal intake

SATIOSTAT treatment + meal intake

ACTIVE COMPARATOR

SATIOSTAT treatment as preload followed by a test meal

Dietary Supplement: SATIOSTAT treatment + meal intake

Interventions

Control treatment + oral glucose DIETARY_SUPPLEMENT

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

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

Control treatment + oral glucose

SATIOSTAT treatment + oral glucose DIETARY_SUPPLEMENT

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

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

SATIOSTAT treatment + oral glucose

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)

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

Control treatment + meal intake

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)

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

SATIOSTAT treatment + meal intake

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obese volunteers (BMI \> 30kg/m2)
• Otherwise healthy
• Informed Consent as documented by signature (Appendix Informed Consent Form)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St Claraspital

Basel, 4016, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucose; CD36 Antigens; Carbohydrates; Proteins

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein

Study Officials

• Christoph Beglinger, MD

  St. Claraspital klinische Forschungsabteilung

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 7, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

CH (1)