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Amino Acid Digestibility of Whey and Zein Proteins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279211
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Benamouzig, Institut National de la Recherche Agronomique

Brief Summary:
The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.

Condition or disease Intervention/treatment Phase
Amino Acid Other: Whey Protein Isolate 894 Fonterra Other: Zein Sigma-Aldrich W555025 Other: Protein-free test-meal Not Applicable

Detailed Description:

True ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins will be determined in healthy subjects. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free test-meal in a different group of subjects.

24 volunteers will be included in the study (men and women; aged 18-65 y; BMI 18-30 kg/m2) and tested at AgroParisTech (Human Nutrition Research Centre of Avicenne Hospital). Due to the invasive procedure of intubation, each volunteer will test only one test-meal (n=8 / test-meal).

One week before the experiment, the volunteers will follow a standard diet adapted to their body weight to control their protein intake (1.3 g protein/kg body weight). The volunteers will arrive at the hospital the morning before the day of the experiment and will be equipped with a double lumen intestinal tube that will be allowed to progress through the intestinal tract for 24h. On the day of the experiment, the position of the tube will be checked by radiography to verify its location at the terminal ileum. A catheter will be inserted in the forearm vein for blood sampling. A perfusion of the non-absorbable marker polyethylene glycol -4000 will start to estimate the intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma sample will be collected. Then, at t=0, the volunteer will drink the test-meal. Until t=9h, intestinal content will be continuously collected by aspiration and pooled every 30 minutes. Blood will be sampled every 30 minutes during 4h and hourly thereafter.

The test meal will consist of a protein-free biscuit (160 g) and a drink (500 ml) with the test protein as the sole source of protein or no protein for the protein-free group. Celite will be added to the protein-free biscuit and inulin labelled with carbon 13 will be added to the drink as indigestible markers of the meal to allow correction for incomplete collection of digesta. The test proteins will be WPI or zein.

The total nitrogen will be measured in meal and digesta samples by the coupling of Elemental Analysis with stable Isotope Ratio Mass Spectrometry (EA-IRMS) and the amino acid concentration in meal, digesta and plasma samples will be measured by High Performance Liquid Chromatography (HPLC) in order to determine the ileal bioavailability of amino acid of zein and whey protein. Plasma hormonal profile will also be determined to evaluate the effect of each protein sources on metabolic hormones such as insulin, glucagon, leptin, etc.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 groups, one for each protein sources (zein and whey) and one for determination of endogenous amino acid losses (protein-free meal)
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: True Ileal Amino Acid Digestibility of Whey and Zein Proteins in Healthy Volunteers With Naso-ileal Tubes
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 20, 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zein protein
Zein protein included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar)
Other: Zein Sigma-Aldrich W555025
30 g of protein powder diluted in water

Experimental: Whey protein isolate
Whey protein isolate included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar)
Other: Whey Protein Isolate 894 Fonterra
30 g of protein powder diluted in water

Protein-free
No protein added in the test-meal, only 500 ml of water + flavour/sugar In order to determine the endogenous loss of amino acid in the digesta samples.
Other: Protein-free test-meal
No protein included in the drink made of water and flavour/sugar




Primary Outcome Measures :
  1. Determination of the concentration of amino acids from dietary sources (whey or zein) in the ileal digesta collected during 9 hours after meal intake to calculate the digestibility of amino acids from whey or zein protein sources. [ Time Frame: Hour 0 to 9 after intake ]
    The quantity of amino acids will be determined by HPLC in the ileal digesta collected thanks to the naso-ileal tube during 9 hours after the meal intake. The obligatory endogenous amino acid losses will be estimated by determination of the amino acid content of ileal digesta after intake of the protein-free meal and this value will be subtracted to the values obtained after intake of protein meal to evaluate the quantity of amino acid which comes from dietary sources. Recovery of the indigestible markers (13C-inulin and celite) will allow correction for incomplete collection of digesta.


Secondary Outcome Measures :
  1. Determination of the metabolic hormones plasma profile after zein or whey protein intake [ Time Frame: Hour 0 to 9 after intake ]
    Blood will be collected hourly during the 9 hours following the intake of the meal containing zein or whey protein. The profile of concentration of metabolic hormones (amylin, C-peptide, ghrelin, gastric inhibitory polypeptide, glucagon-like peptide 1, glucagon, interleukin -6, insulin, leptin, pancreatic polypeptide, polypeptide tyrosine tyrosine , tumor necrosis factor -α) in plasma will be determined by multiplex hormones assays kit.

  2. Determination of the effect of zein and whey protein on glucose homeostasis [ Time Frame: From the evening before the administration to 9 h after the meal. ]
    Subjects are administered oral deuterated water the day before the investigation. Gluconeogenesis is assessed by measuring deuterium enrichment in body water and on C5 glucose position.

  3. Determination of the effect of zein and whey protein on amino acid plasma concentration [ Time Frame: From the evening before the administration to 9 h after the meal. ]
    Blood will be collected hourly during the 9 hours following the intake of the meal containing zein or whey protein. The profile of concentration of amino acids in plasma will be determined by ultra high performance liquid chromatography.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal body weight (18 < BMI < 30 kg.m-2)
  • Women or men
  • 18 - 65 y
  • Healthy
  • Insured under the French social security system
  • Signed informed consent
  • For women: use of birth control

Exclusion Criteria:

  • People under trusteeship
  • Latex, cow milk or corn allergy A
  • HIV, hepatite C virus antibodies, hepatite B virus surface antigen and core antibodies positive
  • Pregnant women
  • Excessive alcohol drinking or drugs intake
  • Hypertension, diabetes, digestive tract, liver or renal diseases, severe heart disease
  • High sport practicing (> 7h/week)
  • Blood donation in the 3 months prior to the study
  • Participation in a clinical study in the 3 months prior to the study
  • No signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279211


Locations
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France
CRNH Ile de France
Bobigny, France, 93900
Sponsors and Collaborators
Institut National de la Recherche Agronomique
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Responsible Party: Robert Benamouzig, Professor, Clinical Head of Gastroenterology, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier: NCT03279211    
Other Study ID Numbers: PROTEOS
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Benamouzig, Institut National de la Recherche Agronomique:
digestibility
whey protein
zein
bioavailability