- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03142737
Are the "Ounce-equivalents" in the Protein Foods Groups Really Equivalent?
12 juni 2019 uppdaterad av: University of Arkansas
The investigators will determine effects of different sources of protein on whole-body net protein synthesis and muscle protein synthesis in young healthy participants.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Over the past 35 years the United States Department of Agriculture (USDA) Dietary Guidelines for Americans (DGAs) has sought to translate recommendations on nutrient requirements (i.e., Recommended Dietary Allowances (RDAs) from the Food and Nutrition Board of the Institute of Medicine (IOM) into practical nutritional advice for the American public.
Over the same time interval in which the Dietary Guidelines have existed the occurrence of nutrition-related health problems in the United States has escalated dramatically, showing that the population of obesity in U.S. has reached to a total of 35.8%.
In addition, the lack of appropriate focus on protein nutrition is a major shortcoming of the DGAs.
Not only is the amount of protein not a major focus, but also absolutely no mention is made of protein quality.
Protein quality refers to the amount, profile, and true ileal digestibility of the essential amino acids (EAAs) in the protein.
However, the concept of protein quality is not new, as the Protein Digestible Corrected Amino Acid Score was published by the Food and Agriculture Organization of the World Health Organization in 1993.
Although animal protein (and beef specifically) has much higher the Digestible Indispensable Amino Acid Score (DIAAS) than plant proteins, often by as much as two fold, DIAAS has not taken account of the importance of the amount and profile of EAAs in individuals proteins.
Moreover, the misrepresentation of the equivalencies of various food sources of protein in MyPlate raises the question of the process by which this occurred, and how can the process be influenced to more accurately reflect that high quality of animal proteins, including beef?
Therefore, we propose to make these measurements in response to intake of "equivalent "(according to MyPlate) amounts of beef, kidney beans, eggs and peanut butter.
Demonstration that the functional responses to these varied sources of protein coincide with the predictions from the USDA nutrient data base and calculation of the DIAAS will provide needed support to redefine "ounce equivalents" of protein food sources according to those data bases for all animal and plant sources of protein.
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72202
- University of Arkansas for Medical Sciences
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Men and women, ages 20-40 years
- BMI from 20 to 29.9 kg/m2
Exclusion Criteria:
- Current diagnosis of diabetes
- History of malignancy in the 6 months prior to enrollment
- History of gastrointestinal bypass surgery
- History of a chronic inflammatory condition or other chronic diseases (Lupus, HIV/AIDS, etc)
- Female subjects who are currently pregnant
- Subjects who are unable to eat animal protein
- Subjects who are unable to stop eating protein or Amino Acid (AA) supplements during the participation
- Subjects who report regular resistance training (more than twice per week)
- Subjects who have concomitant use of corticosteroids (ingestion, injection or transdermal)
- Hemoglobin less than 9.5 g/dL at the screening visit
- Platelets less than 250,000 at the screening visit.
- Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Red kidney bean intake
Subjects will consume 1/2 cup of cooked red kidney bean following diet normalization for 3 days.
|
Each participant will consume 1/2 cup of cooked red kidney bean
|
Experimentell: Eggs intake
Subjects will consume 2 cooked large eggs following diet normalization for 3 days.
|
Each participant will consume 2 cooked large eggs.
|
Experimentell: Peanut butter intake
Subjects will consume 2 tablespoons of peanut butter following diet normalization for 3 days.
|
Each participant will consume 2 tablespoons of peanut butter.
|
Experimentell: Ground beef intake
Subjects will consume 2 ounces of 90% lean ground beef following diet normalization for 3 days.
|
Each participant will consume 2 ounces of 90% lean ground beef.
|
Experimentell: Intact beef intake
Subjects will consume 2 ounces of intact beef following diet normalization for 3 days.
|
Each participant will consume 2 ounces of intact beef.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Net protein synthesis rate
Tidsram: Up to 8.5 hours
|
Net protein synthesis rate is determined in the 4.5-hour basal fasted period and 4-hous post-meal period over the 8.5-hour experimental period
|
Up to 8.5 hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Robert Wolfe, PhD, University of Arkansas
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 maj 2017
Primärt slutförande (Faktisk)
6 mars 2018
Avslutad studie (Faktisk)
15 maj 2019
Studieregistreringsdatum
Först inskickad
2 maj 2017
Först inskickad som uppfyllde QC-kriterierna
4 maj 2017
Första postat (Faktisk)
5 maj 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 205366
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Proteinmetabolism
-
Washington University School of MedicineBASFAvslutad
-
Institut National de la Recherche AgronomiqueAgroParisTechOkänd
-
Ingredia S.A.Avslutad
-
University of ArkansasAvslutadProtein överbelastning
-
University of ArkansasAvslutadProtein | ÄmnesomsättningFörenta staterna
-
Maastricht University Medical CenterFrieslandCampinaAvslutadProtein Digestion & AbsorptionNederländerna
-
University of AarhusAvslutad
-
NIZO Food ResearchFrieslandCampinaAvslutad
-
Pennington Biomedical Research CenterFrank L. Greenway; Corby K. Martin; Jennifer C. Rood; Robbie A. BeylAvslutadProtein | Aminosyra | ArgininFörenta staterna
-
The University of Texas Medical Branch, GalvestonAvslutadDiet | Protein | SkelettmuskelFörenta staterna
Kliniska prövningar på Red kidney bean intake
-
Supplement Formulators, Inc.AvslutadFörändringar i kroppsviktFörenta staterna