Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-10-01
2019-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Zein protein
Zein protein included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar)
Zein Sigma-Aldrich W555025
30 g of protein powder diluted in water
Whey protein isolate
Whey protein isolate included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar)
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.
Protein-free test-meal
No protein included in the drink made of water and flavour/sugar
Interventions
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Whey Protein Isolate 894 Fonterra
30 g of protein powder diluted in water
Zein Sigma-Aldrich W555025
30 g of protein powder diluted in water
Protein-free test-meal
No protein included in the drink made of water and flavour/sugar
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
OTHER
Responsible Party
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Robert Benamouzig
Professor, Clinical Head of Gastroenterology
Locations
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CRNH Ile de France
Bobigny, , France
Countries
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References
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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.
Other Identifiers
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PROTEOS
Identifier Type: -
Identifier Source: org_study_id
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