Bioavailability of Proteins From Plant Based Diets

Sponsor

International Atomic Energy Agency (Other)

Overall Status

Completed

CT.gov ID

NCT04866927

Collaborator

AgroParisTech (Other), Institut National de la Recherche Agronomique (Other), Centre National De L'énergie, Des Sciences Et Techniques Nucléaires (Other)

Enrollment

Location

2.7

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Protein Malabsorption Nutritional Deficiency Nutritional Stunting	Dietary Supplement: Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability

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.

Study Design

Study Type:

Observational

Actual Enrollment :

5 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Use of Stable Isotopic Dilution to Assess Protein Digestibility From Fava Bean and to Evaluate Amino Acid Bioavailability

Actual Study Start Date :

Nov 25, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Relative Amino Acid Digestibility [One year]
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.
DIAAS [One year]
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.

Secondary Outcome Measures

Scientific articles [By the end of 2020]
Publication of scientific reports and peer-reviewed papers and conference presentations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joint Research Unit in Nutrition and Food	Rabat		Morocco	10001

Sponsors and Collaborators

International Atomic Energy Agency
AgroParisTech
Institut National de la Recherche Agronomique
Centre National De L'énergie, Des Sciences Et Techniques Nucléaires

Investigators

Principal Investigator: Mohammed El Mzibri, Head of the Division of Life Sciences - CNESTEN
Study Director: Hassan Aguenaou, Director of Nutrition RDC of Morocco