Effect of Increased Protein Intake on Colonic Metabolism | NCT01280513

Studies
Effect of Increased Protein Intake on Colonic Metabolism

NCT01280513

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Aug 2, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Protein Fermentation
Toxicity in the Colon

Interventions

High protein intake
Low Protein intake

Countries

Belgium

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

Aug 2012

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

Oct 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Not provided

First Submitted Date

Jan 19, 2011

First Submission Date that Met QC Criteria

Jan 19, 2011

First Posted Date

Jan 20, 2011Estimated

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

Aug 1, 2012

Last Update Posted Date

Aug 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Protein intake	Experimental		Dietary Supplement: High protein intake
Low Protein intake	Experimental		Dietary Supplement: Low Protein intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High protein intake	Dietary Supplement	30% of energy intake coming from proteins	High Protein intake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal water toxicity		Participants were followed for 5 weeks, with measurements on 3 specific time points

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Regular eating pattern (3 meals/day)
Age between 18 and 45 years old
BMI between 18,5 and 30 kg/m²

Exclusion Criteria:

Intake of antibiotics in the last month before the study
Abdominal surgeries in the past (accept appendectomy)
Consulting a dietician/following a diet
Vegetarian
Intake of pre- and/or probiotics
Exposure to radioactivity in the year proceeding the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
KULeuven		Leuven	Vlaams-Brabant	3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23285019	Derived	Windey K, De Preter V, Louat T, Schuit F, Herman J, Vansant G, Verbeke K. Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects. PLoS One. 2012;7(12):e52387. doi: 10.1371/journal.pone.0052387. Epub 2012 Dec 20.