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

NCT02956356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-08-08

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Control treatment + oral glucose

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

DIETARY_SUPPLEMENT

SATIOSTAT treatment + oral glucose

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

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)

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)

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Christoph Beglinger, MD · St. Claraspital klinische Forschungsabteilung

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956356 on ClinicalTrials.gov