Inulin,SCFA Production and Metabolic Response
SCFA Production and Their Metabolic Effects After Inulin Ingestion
1 other identifier
interventional
15
1 country
1
Brief Summary
In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Feb 2014
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedNovember 25, 2015
October 1, 2014
5 months
December 9, 2013
November 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fat oxidation, energy expenditure
Fat oxidation and energy expenditure are measured after inulin ingestion
1 study day for each administration
Secondary Outcomes (5)
Hormones that influence substrate and energy metabolism
1 study day for each administration
Circulating metabolites
1 study day for each administration
Appetite VAS scoring
1 study day for each administration
SCFAs
1 study day for each administration
Breath sampling 13CO2
1 study day for each administration
Study Arms (2)
13C inulin
EXPERIMENTAL13C inulin combined with an inulin load are administered orally
Placebo
PLACEBO COMPARATORA placebo is administered orally
Interventions
Eligibility Criteria
You may qualify if:
- Overweight, obese men
You may not qualify if:
- athletes
- diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, 6229ER, Netherlands
Related Publications (1)
van der Beek CM, Canfora EE, Kip AM, Gorissen SHM, Olde Damink SWM, van Eijk HM, Holst JJ, Blaak EE, Dejong CHC, Lenaerts K. The prebiotic inulin improves substrate metabolism and promotes short-chain fatty acid production in overweight to obese men. Metabolism. 2018 Oct;87:25-35. doi: 10.1016/j.metabol.2018.06.009. Epub 2018 Jun 25.
PMID: 29953876DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHC Dejong, MD, PhD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 12, 2013
Study Start
February 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
November 25, 2015
Record last verified: 2014-10