Clinical trial NCT04866927: Bioavailability of Proteins From Plant Based Diets
Official title: Use of Stable Isotopic Dilution to Assess Protein Digestibility From Fava Bean and to Evaluate Amino Acid Bioavailability
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: International Atomic Energy Agency
Sponsor class: OTHER_GOV
Collaborators: name: AgroParisTech
name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
First posted: 2021-04-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals who fit in the inclusion criteria.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative Amino Acid Digestibility
timeFrame: One year
measure: DIAAS
timeFrame: One year
Secondary outcomes:
measure: Scientific articles
timeFrame: By the end of 2020
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Joint Research Unit in Nutrition and Food
Study officials:
affiliation: Head of the Division of Life Sciences - CNESTEN
name: Mohammed El Mzibri
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Nutrition RDC of Morocco
name: Hassan Aguenaou
role: STUDY_DIRECTOR
References: