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Bioavailability of Proteins From Plant Based Diets

NCT ID: NCT04866927

Last Updated: 2021-04-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-25

Study Completion Date

2020-02-15

Brief Summary

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Proteins play an important role as structural and functional components for the human body and prevent stunting. Protein quality has a great importance in meeting the nutritional needs of populations across the world throughout the life course, particularly during pregnancy and early childhood. Dietary protein deficiency is mainly due to protein indigestibility limiting indispensable amino acids (IAAs) bioavailability. In Morocco, as it's the case in many developing countries, diet is mainly based on a large consumption of cereals, fruits, vegetables and pulses, and is generally low in meat, which is the main source of protein and IAA.

The general objective of this study is to evaluate the digestibility of Fava bean proteins and bioavailability of IAA using a dual-tracer method with stable isotopes.

Detailed Description

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This study aims to develop stable isotope labeled protein of bean cultures that could be used for other local common foods, to quantify dietary indispensable amino acids from beans made available to the body for optimal growth, development and function and to participate in the development of a simple method to assess protein quality in vulnerable populations.

The project is divided in two parts: the first part of harvesting and production of deuterium labeled fava beans. The optimization test done the first year has shown that the best protocol for labelling was a pulse with 25% D2O followed with subsequent labeling with 2.5% D2O during 20 days.

The second part is the intervention stuy that is going to be conducted on 6 healthy volunteers (3 males, 3 females). Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.

Conditions

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Protein Malabsorption Nutritional Deficiency Nutritional Stunting

Keywords

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Proteins Digestibility Bioavailability Indispensable Amino Acids Plant-based food Plant diet Nutrition Food security Fava Bean Vegetal proteins

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adults

Inclusion criteria: Healthy, non-pregnant women, adults aged 18-65 years, not taking any medication, including NSAIDs, not taking antibiotics within 4 weeks of study, BMI within 18-35 range.

Exclusion criteria: Children and elderly (over 65), pregnant women, individuals diagnosed with non-communicable or communicable disease, being under restrictive diet, antibiotics within 4 weeks of study, medications within 4 weeks of study.

Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability

Intervention Type DIETARY_SUPPLEMENT

Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.

Interventions

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Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability

Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Healthy, non-pregnant adults 18-65 years of age

Not taking any medication, including NSAIDs Not taking antibiotics within 4 weeks of study BMI within 18-35 range Stable weight

Exclusion Criteria

Children and elderly (over 65)

Pregnancy Diagnosed with non-communicable or communicable disease Being under restrictive diet Antibiotics within 4 weeks of study Medications within 4 weeks of study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AgroParisTech

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Centre National De L'énergie, Des Sciences Et Techniques Nucléaires

OTHER_GOV

Sponsor Role collaborator

International Atomic Energy Agency

OTHER_GOV

Sponsor Role lead

Responsible Party

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Khayour Meriam

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed El Mzibri

Role: PRINCIPAL_INVESTIGATOR

Head of the Division of Life Sciences - CNESTEN

Hassan Aguenaou

Role: STUDY_DIRECTOR

Director of Nutrition RDC of Morocco

Locations

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Joint Research Unit in Nutrition and Food

Rabat, , Morocco

Site Status

Countries

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Morocco

References

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Khayour M, Benmhimdane A, Calvez J, Saeid N, Khodorova N, Belghiti H, El Hamdouchi A, El Kari K, Owino V, Tome D, Aguenaou H, Mentag R, El Mzibri M, Gaudichon C. Indispensable Amino Acid Digestibility of Moroccan Fava Bean Using the Dual Isotope Method in Healthy Adults. J Nutr. 2023 Feb;153(2):451-458. doi: 10.1016/j.tjnut.2022.11.015. Epub 2022 Dec 24.

Reference Type DERIVED
PMID: 36894238 (View on PubMed)

Other Identifiers

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E43031

Identifier Type: -

Identifier Source: org_study_id