Amino Acid Digestibility of Whey and Zein Proteins

NCT03279211 | Completed

• 1 other identifier: PROTEOS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Amino Acid

Keywords

digestibility; whey protein; zein; bioavailability

Outcome Measures

Primary Outcomes (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.

  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.

  Hour 0 to 9 after intake

Secondary Outcomes (3)

• Determination of the metabolic hormones plasma profile after zein or whey protein intake

  Hour 0 to 9 after intake

• Determination of the effect of zein and whey protein on glucose homeostasis

  From the evening before the administration to 9 h after the meal.

• Determination of the effect of zein and whey protein on amino acid plasma concentration

  From the evening before the administration to 9 h after the meal.

Study Arms (3)

Zein protein

EXPERIMENTAL

Zein protein included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar)

Other: Zein Sigma-Aldrich W555025

Whey protein isolate

EXPERIMENTAL

Whey protein isolate included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar)

Other: Whey Protein Isolate 894 Fonterra

Protein-free

OTHER

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

Interventions

Whey Protein Isolate 894 Fonterra OTHER

30 g of protein powder diluted in water

Whey protein isolate

Zein Sigma-Aldrich W555025 OTHER

30 g of protein powder diluted in water

Zein protein

Protein-free test-meal OTHER

No protein included in the drink made of water and flavour/sugar

Protein-free

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead

Study Sites (1)

CRNH Ile de France

Bobigny, 93900, France

Location

Related Publications (1)

• Calvez J, Benoit S, Piedcoq J, Khodorova N, Azzout-Marniche D, Tome D, Benamouzig R, Airinei G, Gaudichon C. Very low ileal nitrogen and amino acid digestibility of zein compared to whey protein isolate in healthy volunteers. Am J Clin Nutr. 2021 Jan 4;113(1):70-82. doi: 10.1093/ajcn/nqaa274.

  PMID: 33021640 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Head of Gastroenterology

Model Details: 3 groups, one for each protein sources (zein and whey) and one for determination of endogenous amino acid losses (protein-free meal)

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: September 12, 2017
• Study Start: October 1, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

FR (1)