Hemodialysis and Wanting for Protein-rich Foods

Renal Failure Clinical Trial

Official title:

Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221050
• Other study ID #: 2013/28
• Status: Completed
• Phase: N/A
• First received: August 13, 2014
• Last updated: August 19, 2014
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: University of Burgundy
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
France	Centre des Sciences du Goût	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
University of Burgundy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)	Yes
Secondary	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	8:30 am and 11:30 am	Yes