Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach
|ClinicalTrials.gov Identifier: NCT01718418|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : May 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obesity Metabolic Syndrome||Other: test meal Other: reference||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: + ind.CHO + prebiotics
test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.
|Other: test meal|
Experimental: + ind.CHO - prebiotics
test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.
|Other: test meal|
Experimental: - ind.CHO - prebiotics
reference: no ind. carbohydrates and no probiotic supplement
- Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal. [ Time Frame: 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.
- voluntary energy intake [ Time Frame: 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.
- Subjective satiety [ Time Frame: post-prandially after breakfast, 0-210 min ]The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.
- Differences in gut microbiota [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718418
|Applied Nutrition and Food Chemistry, Lund University|
|Lund, Sweden, SE-221 00|
|Principal Investigator:||Anne Nilsson, PhD||Lund University|