Renal FailureNCT02221050
Hemodialysis and Wanting for Protein-rich Foods
An observational study of Renal Failure, run by University of Burgundy at 1 site in France.
Trial summary
A study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. This period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jul 2014
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hemodialysis centers of Clinique Drevon, Dijon, France la Breuchillière, Saint Apollinaire, France University Hospital, Dijon, France Macon Hospital, Macon, France
Who may be able to join
- Patients and healthy subjects were included if they were aged between 18 and 80 years
Who cannot join
- diabetes, advanced undernutrition (BMI < 17.5 kg m-2, prealbumin < 250 mg.L-1), congestive heart failure, acute or chronic infection, ongoing antibiotic treatment, active cancer, liver cirrhosis, smoking (more than 5 cigarettes/day), alcohol consumption (more than 3 units/day), aversion to the foods eaten or smelt during the study, impaired comprehension of the cognitive tasks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods
A study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. This period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. It therefore appears necessary to understand the mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone), leptin (anorectic hormone) and plasma amino acids.
Read the detailed description
In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at 11:00 am), a day without hemodialysis and another day after the hemodialysis:
- Hunger sensation,
- Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2 protein-rich foods) and 2 non-alimentary products,
- Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6 carbohydrate- and 6 protein-rich foods),
- Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin as well as plasma amino acids. 24 healthy subjects are also evaluated in order to compare the results from patients to those of control subjects.
- Conditions
- Renal Failure
- Medical subject headings
- Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of wanting for protein-rich foods
The wanting is determined after the successive presentation (for ten seconds) of 18 pictures of food. For each food the question is "at the present time, do you want to eat this food? ". For each photo, subjects place a vertical line on a 10 cm horizontal line bounded at its ends by "no desire" and "extremely envy" (visual analog scale).The wanting for proteins is the mean score for the desire to eat protein-rich foods.
Measured: 20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)
Secondary outcomes (1)
Concentrations of the plasma amino-acids
Variation in concentrations of amino-acids during the morning a day with hemodialysis and a day without hemodialysis, and comparison with plasma AAs from healthy subjects
Measured: 8:30 am and 11:30 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionJul 2014
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 Renal FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent BRONDEL, University of Burgundy
- Investigators
- Luc PENICAUD, PHD, Study director, Centre des Sciences du Goût, Centre National de la recherche Scientifique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221050
- Sponsor's protocol ID
- 2013/28
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mouillot T, Filancia A, Boirie Y, Brindisi MC, Hafnaoui N, Van Wymelbeke V, Teillet E, Meintani I, Jacquin-Piques A, Leloup C, Penicaud L, Mousson C, Brondel L. Hemodialysis Affects Wanting and Spontaneous Intake of Protein-Rich Foods in Chronic Kidney Disease Patients. J Ren Nutr. 2021 Mar;31(2):164-176. doi: 10.1053/j.jrn.2020.05.006. Epub 2020 Jul 25.
PubMed 32723525
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods
- ClinicalTrials.gov ID
- NCT02221050
- Acronym / sponsor ID
- 2013/28
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Aug 2014 (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.
A study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. This period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. It therefore appears necessary to understand the mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone), leptin (anorectic hormone) and plasma amino acids.
Detailed description
In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at 11:00 am), a day without hemodialysis and another day after the hemodialysis:
- Hunger sensation,
- Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2 protein-rich foods) and 2 non-alimentary products,
- Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6 carbohydrate- and 6 protein-rich foods),
- Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin as well as plasma amino acids. 24 healthy subjects are also evaluated in order to compare the results from patients to those of control subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis centers of Clinique Drevon, Dijon, France la Breuchillière, Saint Apollinaire, France University Hospital, Dijon, France Macon Hospital, Macon, France
Key inclusion criteria (1 listed)
- Patients and healthy subjects were included if they were aged between 18 and 80 years
Key exclusion criteria (1 listed)
- diabetes, advanced undernutrition (BMI < 17.5 kg m-2, prealbumin < 250 mg.L-1), congestive heart failure, acute or chronic infection, ongoing antibiotic treatment, active cancer, liver cirrhosis, smoking (more than 5 cigarettes/day), alcohol consumption (more than 3 units/day), aversion to the foods eaten or smelt during the study, impaired comprehension of the cognitive tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of wanting for protein-rich foods
Time frame: 20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)
The wanting is determined after the successive presentation (for ten seconds) of 18 pictures of food. For each food the question is "at the present time, do you want to eat this food? ". For each photo, subjects place a vertical line on a 10 cm horizontal line bounded at its ends by "no desire" and "extremely envy" (visual analog scale).The wanting for proteins is the mean score for the desire to eat protein-rich foods.
1 secondary outcome
Concentrations of the plasma amino-acids
Time frame: 8:30 am and 11:30 am
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 20 Aug 2014.
- Derived from this study: PubMed 32723525Mouillot T, Filancia A, Boirie Y, Brindisi MC, Hafnaoui N, Van Wymelbeke V, Teillet E, Meintani I, Jacquin-Piques A, Leloup C, Penicaud L, Mousson C, Brondel L. Hemodialysis Affects Wanting and Spontaneous Intake of Protein-Rich Foods in Chronic Kidney Disease Patients. J Ren Nutr. 2021 Mar;31(2):164-176. doi: 10.1053/j.jrn.2020.05.006. Epub 2020 Jul 25.
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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.
Luc PENICAUD, PHD study director
Centre des Sciences du Goût, Centre National de la recherche Scientifique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure, run by University of Burgundy at 1 site in France.
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 1 inclusion and 1 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 20 Aug 2014. 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 France. 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?
Amount of wanting for protein-rich foods (time frame: 20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)). 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 NCT02221050, 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 20 Aug 2014.