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
  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 Blind (Subject, Investigator)
Official Title: The Effects of Differential Short Chain Fatty Acid Availability on Human Substrate and Energy Metabolism

Resource links provided by NLM:


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 ] [ 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


Secondary Outcome Measures:
  • 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


Enrollment: 8
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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight, obese men

Exclusion Criteria:

  • athletes
  • diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01826162     History of Changes
Other Study ID Numbers: MEC 11-3-079
Study First Received: February 18, 2013
Last Updated: August 20, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014