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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

Tracking Information
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
 (submitted: August 19, 2014)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 19, 2014)
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
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:

  • 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2014)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Study Director: Luc PENICAUD, PHD Centre des Sciences du Goût, Centre National de la recherche Scientifique
PRS Account University of Burgundy
Verification Date August 2014