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Short Chain Fatty Acid Metabolism and Energy Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01826162
First Posted: April 8, 2013
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus Obesity Other: acetate or placebo infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effects of Differential Short Chain Fatty Acid Availability on Human Substrate and Energy Metabolism

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: April 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sigmoidoscopy
2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the proximal colon (sigmoidoscopy)
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)
Other: acetate or placebo infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight, obese men

Exclusion Criteria:

  • athletes
  • diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826162


Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6200 MD
Maastricht University
Maastricht, Netherlands, 6200
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: Ellen Blaak, Prof. Maastricht University
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01826162     History of Changes
Other Study ID Numbers: MEC 11-3-079
First Submitted: February 18, 2013
First Posted: April 8, 2013
Last Update Posted: September 15, 2015
Last Verified: August 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases