- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983046
Rectal Short Chain Fatty Acids Combinations and Substrate and Energy Metabolism
October 20, 2014 updated by: Maastricht University Medical Center
The Effects of Rectal Administration of SCFA 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 fiber, is still controversial.
One study found that an increase in the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain.
In contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in SCFA formation, had beneficial effects on body weight control and insulin sensitivity.
Of note, a study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin resistance.
At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited.
Yet, in light of the health claims of certain dietary fibers (prebiotics), a detailed picture of the physiology of human SCFA metabolism and its interaction with the microbiome is of pivotal importance.
We hypothesize that the differential availability of SCFA impacts human metabolism differently.
To determine whether rectal administration of SCFA is a good model for studying the metabolic effects of SCFA we first have performed a pilot study (METC 11-3-079).
In this pilot study we have determined if rectal administration of sodium acetate has the same effects on substrate and energy metabolism compared to proximal administration.
Our results indicate that the primary outcome parameter fat oxidation was significantly changed during post-absorptive conditions, when sodium acetate in a concentration of 180mM was administered in the distal part of the colon.
In contrast, no effect on energy expenditure or substrate oxidation was seen when sodium acetate was administered in the proximal colon.
Consequently, the distal part of the colon seems to be a good model to determine effects of gut-derived SCFA on the human substrate and energy metabolism.
Therefore, we will administer in this study the SCFA rectally by using enemas.
We will administer different combinations of SCFA to healthy, overweight male volunteers and examine effects on metabolism.
This study is an important part of a Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide more insight in how increased availability of a beneficial SCFA mixture might serve as a basis for rational nutritional strategies in the prevention and treatment of obesity and type 2 diabetes mellitus.
To obtain rational nutritional strategies, a next step in this TIFN project will be focusing on dietary ingredients modulating intestinal microbiota and subsequent SCFA production.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Limburg
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Maastricht, Limburg, Netherlands, 6229 ER
- University Maastricht
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Overweight
- Obese men
Exclusion Criteria:
- Athletes
- Diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
|
Active Comparator: high acetate ratio
|
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Active Comparator: high butyrate ratio
|
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Active Comparator: high propionate ratio
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fat oxidation
Time Frame: 4 hours total (2 hours fasting, 2 hours postprandial)
|
we will measure fat oxidation and energy expenditure by using the ventilated hood system
|
4 hours total (2 hours fasting, 2 hours postprandial)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hormones that influence energy metabolism
Time Frame: 4 hours total (2 hours fasting and 2 hours postprandial)
|
4 hours total (2 hours fasting and 2 hours postprandial)
|
Circulating metabolites
Time Frame: 4 hours total (2 hours fasting and 2 hours postprandial)
|
4 hours total (2 hours fasting and 2 hours postprandial)
|
Hormones that influence energy metabolism - Circulating metabolites - Inflammatory markers - plasma SCFA content; - Indirect markers of insulin sensitivity - Appetite (VAS-scoring).
Time Frame: 4 hours total (2 hours fasting and 2 hours postprandial)
|
4 hours total (2 hours fasting and 2 hours postprandial)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
September 17, 2013
First Submitted That Met QC Criteria
November 12, 2013
First Posted (Estimate)
November 13, 2013
Study Record Updates
Last Update Posted (Estimate)
October 21, 2014
Last Update Submitted That Met QC Criteria
October 20, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- NL44507.068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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