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

Obesity Clinical Trial

Official title:

Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718418
• Other study ID #: Dnr2010/457
• Status: Completed
• Phase: Phase 0
• First received: October 9, 2012
• Last updated: May 7, 2013
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Other:
• test meal

• reference

Locations

Country	Name	City	State
Sweden	Applied Nutrition and Food Chemistry, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.	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.	Post-prandially after breakfast, 0-210 min	No
Secondary	voluntary energy intake	Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.	Post-prandially after breakfast, 0-210 min	No
Secondary	Subjective satiety	The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.	post-prandially after breakfast, 0-210 min	No
Secondary	Differences in gut microbiota	The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.	Faecal samples are collected after 14 days intake of test- and reference product	No