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Hemodialysis and Wanting for Protein-rich Foods

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ClinicalTrials.gov Identifier: NCT02221050
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Laurent BRONDEL, University of Burgundy

Study Description
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Brief 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. 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.

Condition or disease
Renal Failure

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 15 Days
Official Title: Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods
Study Start Date : January 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Concentrations of the plasma amino-acids [ Time Frame: 8:30 am and 11:30 am ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
hemodialysis centers of Clinique Drevon, Dijon, France la Breuchillière, Saint Apollinaire, France University Hospital, Dijon, France Macon Hospital, Macon, France
Criteria

Inclusion Criteria:

  • Patients and healthy subjects were included if they were aged between 18 and 80 years

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221050


Locations
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France
Centre des Sciences du Goût
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
University of Burgundy
Investigators
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Study Director: Luc PENICAUD, PHD Centre des Sciences du Goût, Centre National de la recherche Scientifique
More Information
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Additional Information:

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Responsible Party: Laurent BRONDEL, University professor, University of Burgundy
ClinicalTrials.gov Identifier: NCT02221050    
Other Study ID Numbers: 2013/28
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases