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
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Sponsor:
University of Burgundy
Information provided by (Responsible Party):
Laurent BRONDEL, University of Burgundy
Tracking Information | ||||
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First Submitted Date | August 13, 2014 | |||
First Posted Date | August 20, 2014 | |||
Last Update Posted Date | August 20, 2014 | |||
Study Start Date | January 2014 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures |
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
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Hemodialysis and Wanting for Protein-rich Foods | |||
Official Title | Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods | |||
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. | |||
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:
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Study Type | Observational [Patient Registry] | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | 15 Days | |||
Biospecimen | Not Provided | |||
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 | |||
Condition | Renal Failure | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
48 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | July 2014 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02221050 | |||
Other Study ID Numbers | 2013/28 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Laurent BRONDEL, University of Burgundy | |||
Study Sponsor | University of Burgundy | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University of Burgundy | |||
Verification Date | August 2014 |