Protein FermentationNCT01280513
Effect of Increased Protein Intake on Colonic Metabolism
A study testing High protein intake and Low Protein intake in people with Protein Fermentation and Toxicity in the Colon, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Fermentation, Toxicity in the Colon
- What is being tested?
- High protein intake and Low Protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Regular eating pattern (3 meals/day)
- Age between 18 and 45 years old
- BMI between 18,5 and 30 kg/m²
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.
The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.
- Conditions
- Protein Fermentation, Toxicity in the Colon
- Being tested
- High protein intake, Low Protein intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein intakeDietary supplement
30% of energy intake coming from proteins
Low Protein intakeDietary supplement
9% of energy intake coming from proteins
| Study group | Role | What they receive |
|---|---|---|
| High Protein intake | Experimental | Not described Receives: Dietary Supplement: High protein intake |
| Low Protein intake | Experimental | Not described Receives: Dietary Supplement: Low Protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal water toxicity
Measured: Participants were followed for 5 weeks, with measurements on 3 specific time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein FermentationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280513
- Sponsor's protocol ID
- ML5174
- Status last verified
- Aug 2012
- First submitted
- 19 Jan 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23285019
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01280513
- Acronym / sponsor ID
- ML5174
- Conditions
- Protein Fermentation, Toxicity in the Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein intake | Experimental | Dietary Supplement: High protein intake |
| Low Protein intake | Experimental | Dietary Supplement: Low Protein intake |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Regular eating pattern (3 meals/day)
- Age between 18 and 45 years old
- BMI between 18,5 and 30 kg/m²
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein intake30% of energy intake coming from proteins | Dietary supplement | High Protein intake |
| Low Protein intake9% of energy intake coming from proteins | Dietary supplement | Low Protein intake |
Primary outcome
Fecal water toxicity
Time frame: Participants were followed for 5 weeks, with measurements on 3 specific time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 23285019Windey 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein intake and Low Protein intake in people with Protein Fermentation and Toxicity in the Colon, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal water toxicity (time frame: Participants were followed for 5 weeks, with measurements on 3 specific time points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.