Bioavailability of Proteins From Plant Based Diets

Study Overview
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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.

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

Conditions
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Protein Malabsorption, Nutritional Deficiency, Nutritional Stunting

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scientific articles | Publication of scientific reports and peer-reviewed papers and conference presentations. | By the end of 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digestibility, Proteins, Bioavailability, Indispensable Amino Acids, Plant-based food, Plant diet, Nutrition, Food security, Fava Bean, Vegetal proteins