Bioavailability of Proteins From Plant Based Diets

NCT04866927 | Completed

• 1 other identifier: E43031
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Protein Malabsorption; Nutritional Deficiency; Nutritional Stunting

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Relative Amino Acid Digestibility

  The digestibility of each IAA from the 13C-labeled spirulina protein and TCF is an IAA-specific term used to correct for loss of a 2H atom during transamination.

  One year

• DIAAS

  The digestible indispensable amino acid score (DIAAS), representing the content of each IAA, along with the digestibility of each IAA, in relation to the human requirement pattern was also calculated.

  One year

Secondary Outcomes (1)

• Scientific articles

  By the end of 2020

Study Arms (1)

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.

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

Interventions

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

Adults

Eligibility Criteria

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

Study Population

Healthy individuals who fit in the inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Atomic Energy Agency: lead
• AgroParisTech: collaborator
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• Centre National De L'énergie, Des Sciences Et Techniques Nucléaires: collaborator

Study Sites (1)

Joint Research Unit in Nutrition and Food

Rabat, 10001, Morocco

Location

Related Publications (1)

• 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.

  PMID: 36894238 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mohammed El Mzibri

  Head of the Division of Life Sciences - CNESTEN

  PRINCIPAL INVESTIGATOR

• Hassan Aguenaou

  Director of Nutrition RDC of Morocco

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 30, 2021
• Study Start: November 25, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 15, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

MO (1)