Fiber Fermentation Kinetics Inside the Gut, and Utilizati... | NCT04013607

Studies
Fiber Fermentation Kinetics Inside the Gut, and Utilization of Bacterial Metabolites

NCT04013607

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Metabolism
Dietary Fiber
Intestine

Interventions

fructo- and galacto-oligosaccharides

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2019Actual

Primary Completion Date

Oct 17, 2019Actual

Completion Date

Oct 17, 2019Actual

First Submitted Date

Apr 23, 2019

First Submission Date that Met QC Criteria

Jul 4, 2019

First Posted Date

Jul 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2020

Last Update Posted Date

Oct 14, 2020Actual

Name	Class
University Medical Center Groningen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the life course of SCFA and their regulatory role in human metabolism will be traced using a nose-intestine catheter. The investigators have methodological questions: investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to establish the time points of plasma sampling (to determine systemic availability of SCFAs). The resulting timepoints established in this pilot study will be applied during a future human intervention study.

Detailed Description

Background: Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC are fermented by the microbiota, hereby producing fermentation end products, mainly short chain fatty acids (SCFA) acetate, butyrate, and propionate. It is hypothesized that SCFAs mediate parts of the beneficial effects of NDC. In mice, the influx of SCFA into the host correlated strongly with improvements of markers of the metabolic syndrome, whereas concentrations of SCFA in the cecum did not. The production and influx/incorporation of SCFAs in humans will be investigated.

Study design: At day 1 the catheter will be placed. After an overnight fast at day 2, 5 subjects will consume a NDC bolus. Isotopically 13C-labelled SCFAs will be delivered in the cecum. Samples will be taken in the cecum and blood before, and continuously after dispensing the 13C-labelled SCFAs.

Study population: 5 healthy male volunteers (18-60yrs, and BMI between 18.5-30 kg/m2).

Main study parameters/endpoints: (isotopic) enrichments of SCFAs in cecum, and label incorporation in plasma metabolites such as organic acids, glucose, cholesterol, fatty acids.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fiber drink	Experimental	A drink high in fructo- and galacto-oligosaccharides.	Dietary Supplement: fructo- and galacto-oligosaccharides

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fructo- and galacto-oligosaccharides	Dietary Supplement	A NDC drink rich in fructo- and galacto-oligosaccharides	Fiber drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of SCFAs	(13C isotopic) enrichments of SCFAs inside intestinal lumen by GC-MS	Between 0 and 10 hours
Concentrations of plasma metabolites	(13-C isotopic label incorporation) in plasma metabolites by GC-MS	Between 0 and 10 hours

Secondary Outcomes

Measure	Description	Time Frame
Concentrations of organic acids	Organic acids measured in plasma and intestinal lumen by GC-MS	Between 0 and 10 hours
Concentrations of carbohydrates	mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen by GC-MS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males
Age 18-60yrs
BMI between 18.5 and 30 kg/m2
Regular bowel movement (defaecation on average once a day)
Signed informed consent

Exclusion Criteria:

Having a history of medical or surgical events that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study (e.g. diabetes, cardiovascular disease, gastrointestinal disease, renal failure, cancer, infectious disease, nose/throat).
Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, and herbal remedies during the three (3) weeks prior to study start.
Carrying a pacemaker or any other (implanted) medical electronic device
Smoker
Unstable body weight (weight gain or loss >5kg in the past 3 months prior to the study start)
Use of antibiotics within 3 months of starting the study or planned during the study
Use of pro- or prebiotics (e.g. galacto-oligosaccharides, fructo-oligosaccharides)
Constipation/infrequent bowel movement
Abuse of drugs/alcohol (alcohol: >4 consumptions/day or >21 consumptions/week)
Participation in another biomedical study
Having diarrhoea within 2 months prior to the study start
Personnel of Wageningen University, Division of Human Nutrition, their partner and their first and second degree relatives
Current participation in other research from the Division of Human Nutrition
Not willing to have an X-ray
Having blood vessels that are too difficult for inserting a cannula
Having a hemoglobin of <8.4 mmol/L

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Guido Hooiveld, PhD	Wageningen University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Wageningen University		Wageningen	Gelderland	6708 WE	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25203112	Background	den Besten G, Havinga R, Bleeker A, Rao S, Gerding A, van Eunen K, Groen AK, Reijngoud DJ, Bakker BM. The short-chain fatty acid uptake fluxes by mice on a guar gum supplemented diet associate with amelioration of major biomarkers of the metabolic syndrome. PLoS One. 2014 Sep 9;9(9):e107392. doi: 10.1371/journal.pone.0107392. eCollection 2014.
24136789