- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02221050
Hemodialysis and Wanting for Protein-rich Foods
Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Burgundy
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Dijon, Burgundy, Frankrig, 21000
- Centre des Sciences du Goût
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Amount of wanting for protein-rich foods
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Concentrations of the plasma amino-acids
Tidsramme: 8:30 am and 11:30 am
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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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Luc PENICAUD, PHD, Centre des Sciences du Goût, Centre National de la recherche Scientifique
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013/28
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