NCT04118517

Brief Summary

Dietary Protein quality is based on digestion of proteins to amino acids and the bioavailability of the amino acids to maintain good health and body function. Currently, digestibility of proteins, which is measured as the difference between protein intake and faecal loss, is underestimated. This is because, in addition to loss from dietary proteins, faecal loss includes additional protein from gut secretions and bacteria residing in the large intestine. The expert committee on protein quality suggested that a minimally invasive accurate method based on Dual Stable Isotope Tracer approach (non-radioactive) could be developed. This method is based on the concept that if amino acids in proteins become labelled with an isotopic tracer within the food matrix, their appearance in the blood gives a measure of bioavailability. The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) are promoting peas and beans to combat poverty, hunger and malnutrition because they are relatively less expensive sources of protein. We hypothesized that digestibility of protein in the common bean and absorption of amino acids is higher than current estimates. The aim of this proposal is to conduct a study in 12 healthy adults, aged 20 to 45 years, to test a novel method to assess protein quality of the common bean using the isotopic approach. The Scientific Research Council will grow the labelled beans by adding a tracer dose of deuterium to the irrigation water. The beans are prepared a typical Jamaican meal for consumption. The meal is mixed with a labelled reference protein (U-13C-spirulina) which is universally (U) labelled with stable isotope 13-Carbon (13C) to estimate digestibility; and the amino acid, phenylalanine, in which the 6 ring carbon atoms are labelled with 13C (ring-13C6- phenylalanine) to provide an index of amino acids absorption. Before and after consumption of the meal, samples of blood, breath and urine will be taken. These samples and a sample of the diet will be analysed for amino acids composition and deuterium enrichment using mass-spectrometry. The appearance of each labelled essential amino acid in blood from the bean protein will be calculated. The data will provide accurate date on amino acids bioavailability from the common bean that will be useful for dietary guideline for good health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2021

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

October 5, 2019

Last Update Submit

September 12, 2022

Conditions

Keywords

protein quality, legume

Outcome Measures

Primary Outcomes (3)

  • Digestibility of protein from the common bean

    Measured by comparing plasma enrichment of each deuterium labelled indispensable amino acid (IAA) from the bean to plasma enrichment of the same 13C- labelled IAA from a highly digestible reference protein (Universally 13C-labelled spirulina)

    8h

  • Absorption index of amino acids

    Calculated based on the enrichment of free L-\[ring-13C6\]-phenylalanine in plasma at steady state divided by its enrichment in the meal.

    8h

  • Digestible indispensable amino acids score

    mg of digestible bean IAA in 1g bean protein/ mg of the same IAA in 1g reference protein

    8h

Study Arms (1)

test meal

EXPERIMENTAL

The study comprises one arm of 12 healthy Jamaican male and female adults with normal body mass inex, aged 20 to 45 years, receiving a test meal containing the common bean that was intrinsically labelled with deuterium .

Other: Using intrinsically labelled bean protein to assess bioavailability of amino acids in healthy adults

Interventions

The intervention comprises a test meal of intrinsically deuterium labelled stewed common bean with rice. The meal is mixed with a reference protein (Universally labelled 13C-spirulina, 12 mg/kg) and 13C6-Phenylalanine (0.05mg/kg) which is divided into equal mini meals and fed hourly over 8 hours. Protein in the total meal provides 15% of the energy intake with the labelled bean contributing \>50% of the protein.

Also known as: Testing quality of bean protein in a feeding trial
test meal

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range - 20-45 years
  • BMI range- 18.5 - 25 kg/m2
  • Male or Female
  • No food allergies

You may not qualify if:

  • History of diabetes
  • History of hypertension, any chronic illness
  • Acute illness within the last 2 weeks
  • Involved in competitive sports
  • Altered sleep/ eating schedules
  • Weight loss or gain in the past six months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Metabolism Research Unit, Caribbean Institute for Health Research, University of the West Indies

Kingston, KN6, Jamaica

Location

Related Publications (11)

  • Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover.

    PMID: 18330140BACKGROUND
  • Food and Agriculture Organization, Protein quality evaluation. Report of the Joint FAO/WHO Expert Consultation. FAO food and Nutrition paper 5. FAO 1991

    BACKGROUND
  • Duggleby SL, Jackson AA. Relationship of maternal protein turnover and lean body mass during pregnancy and birth length. Clin Sci (Lond). 2001 Jul;101(1):65-72.

    PMID: 11410116BACKGROUND
  • Hoddinott J, Maluccio JA, Behrman JR, Flores R, Martorell R. Effect of a nutrition intervention during early childhood on economic productivity in Guatemalan adults. Lancet. 2008 Feb 2;371(9610):411-6. doi: 10.1016/S0140-6736(08)60205-6.

    PMID: 18242415BACKGROUND
  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND
  • Moughan PJ. Amino acid availability: aspects of chemical analysis and bioassay methodology. Nutr Res Rev. 2003 Dec;16(2):127-41. doi: 10.1079/NRR200365.

    PMID: 19087386BACKGROUND
  • Fuller MF, Tome D. In vivo determination of amino acid bioavailability in humans and model animals. J AOAC Int. 2005 May-Jun;88(3):923-34.

    PMID: 16001870BACKGROUND
  • Dietary protein quality evaluation in human nutrition. Report of an FAQ Expert Consultation. FAO Food Nutr Pap. 2013;92:1-66. No abstract available.

    PMID: 26369006BACKGROUND
  • World Health Organization (2012), Technical Note: Supplementary foods for the management of moderate acute malnutrition in infants and children 6-59 months of age, WHO, Geneva.

    BACKGROUND
  • Lee WT, Weisell R, Albert J, Tome D, Kurpad AV, Uauy R. Research Approaches and Methods for Evaluating the Protein Quality of Human Foods Proposed by an FAO Expert Working Group in 2014. J Nutr. 2016 May;146(5):929-32. doi: 10.3945/jn.115.222109. Epub 2016 Apr 6.

    PMID: 27052532BACKGROUND
  • CGIAR. 2012. CGIAR Research Program on Grain Legumes Leveraging legumes to combat poverty, hunger, malnutrition and environmental degradation. Consortium of International Agricultural Research Centers, Montpellier.

    BACKGROUND

Study Officials

  • Asha V Badaloo, PhD

    University of the West Indies, Mona Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The model is based on the concept that if amino acids in protein become labelled with an isotopic tracer within the food matrix, their appearance in the blood gives a measure of their bioavailability following digestion and absorption of the protein; which is independent of other proteins in the food and independent of endogenous body proteins and gut bacterial proteins. Amino acids in the common bean were labelled with deuterium, by adding a bolus dose of deuterium oxide (2H2O) to the irrigation water. Then a dual tracer technique is used to measure the bioavailability of amino acids in the bean. After consuming a diet prepared with the mature bean, comparative tracer appearance in blood of the deuterium labelled amino acids from the bean and amino acids derived from a reference protein labelled within another tracer (U-13C- spirulina) gives a direct measure of bioavailability of the bean amino acids.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2019

First Posted

October 8, 2019

Study Start

May 29, 2019

Primary Completion

July 27, 2020

Study Completion

July 3, 2021

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations