- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221050
Hemodialysis and Wanting for Protein-rich Foods
Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Burgundy
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Dijon, Burgundy, France, 21000
- Centre des Sciences du Goût
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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8:30 am and 11:30 am
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Luc PENICAUD, PHD, Centre des Sciences du Goût, Centre National de la recherche Scientifique
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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