NCT Number: NCT01826162
Short Chain Fatty Acid Metabolism and Energy Metabolism
Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the differential availability of SCFA impacts human metabolism differently.
In this placebo controlled, double-blind, randomized crossover pilot study the investigators will validate in overweight/obese healthy male volunteers whether rectal administration of SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be investigated if site of administration (in distal or proximal colon) of SCFA differentially affects parameters of substrate and energy metabolism and to test the duration of short-term effects of SCFA administration.
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Conditions
Age range
20 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Maastricht University, Maastricht, Limburg, Netherlands
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Overweight, obese men
Exclusion criteria
- athletes
- diabetes mellitus
Treatment and study plan
Primary outcomes
-
Fat oxidation, energy expenditure
Time frame: 1 study day for each administration
Fat oxidation and energy expenditure are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Secondary outcomes
-
Hormones that influence substrate and energy metabolism
Time frame: 1 study day for each administration
Insulin, Glucagon, GLP-1, PYY and Leptin are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
-
Inflammatory markers
Time frame: 1 study day for each administration
LBP, TNF-α, IL-6, IL-1 are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
-
Plasma SCFA content
Time frame: 1 study day for each administration
Plasma SCFA content (acetate, butyrate and propionate) are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
-
Circulating metabolites
Time frame: 1 study day for each administration
Glucose, FFA, TG, Glycerol, FIAF are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
-
Appetite VAS scoring
Time frame: 1 study day for each administration
Visual Analogue Scale for hunger and appetite are filled in during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Sponsors and collaborators
Lead sponsor
Maastricht University Medical Center
Other
Collaborators
- Top Institute Food and Nutrition
Registry information
Official study title
The Effects of Differential Short Chain Fatty Acid Availability on Human Substrate and Energy Metabolism
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Apr 8, 2013
- Registry last updated
- Sep 15, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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