Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach

Early Phase 1

Completed

• Conditions: Obesity; Metabolic Syndrome

• Registration Number: NCT01718418
• Lead Sponsor: Lund University

Brief Summary

The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives

Exclusion Criteria

• gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.	Post-prandially after breakfast, 0-210 min	Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.

Secondary Outcome Measures

Name	Time	Method
voluntary energy intake	Post-prandially after breakfast, 0-210 min	Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.
Differences in gut microbiota	Faecal samples are collected after 14 days intake of test- and reference product	The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.
Subjective satiety	post-prandially after breakfast, 0-210 min	The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.

Trial Locations

Locations (1)

Applied Nutrition and Food Chemistry, Lund University; 🇸🇪 Lund, Sweden