Short Chain Fatty Acid Metabolism and Energy Metabolism

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01826162
First received: February 18, 2013
Last updated: August 20, 2013
Last verified: August 2013

February 18, 2013
August 20, 2013
April 2013
June 2013   (final data collection date for primary outcome measure)
Fat oxidation, energy expenditure [ Time Frame: 1 study day for each administration ] [ Designated as safety issue: No ]
Fat oxidation and energy expenditure are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Same as current
Complete list of historical versions of study NCT01826162 on ClinicalTrials.gov Archive Site
  • Hormones that influence substrate and energy metabolism [ Time Frame: 1 study day for each administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
  • Hormones that influence substrate and energy metabolism [ Time Frame: 1 study day for each administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Visual Analoge Scale for hunger and appetite are filled in during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Not Provided
Not Provided
 
Short Chain Fatty Acid Metabolism and Energy Metabolism
The Effects of Differential Short Chain Fatty Acid Availability on Human Substrate 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
  • Type 2 Diabetes Mellitus
  • Obesity
Other: acetate or placebo infusion
  • Experimental: sigmoidoscopy
    2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the proximal colon (sigmoidoscopy)
    Intervention: Other: acetate or placebo infusion
  • Experimental: colonoscopy
    2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the distal colon (colonoscopy)
    Intervention: Other: acetate or placebo infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Overweight, obese men

Exclusion Criteria:

  • athletes
  • diabetes mellitus
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01826162
MEC 11-3-079
No
Maastricht University Medical Center
Maastricht University Medical Center
Top Institute Food and Nutrition
Principal Investigator: Ellen Blaak, Prof. Maastricht University
Maastricht University Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP