Bioavailability of Proteins From Plant Based Diets

NCT03492190 | Unknown DMC

• 1 other identifier: 2207
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The quality of protein intake has an important role within the nutritional needs of people throughout their lives around the world, particularly in developing countries and in particular during pregnancy and early childhood. It is likely that adequate protein reduce by 40% the prevalence of stunting (low height for age) in children under five years, according to World Health Organization data. Uncertainty about the quality of the diet, specifically with reference to quality proteins has potential impacts on health, economy, agriculture, and food security of a nation. The amino acid digestibility estimates based on stool analysis do not represent the amount of absorbed amino acid. Ideally, the bioavailable amino acid should be measured by methods that assess the difference between consumed and absorbed amino acids. However, the uptake of amino acids is not readily non-invasively measured in healthy humans. The use of vegetable protein intrinsically labeled by stable isotopes offers a solution to this problem. The deuterated water (2H2O), with relatively low cost, is suitable for labeling plant proteins such as those of beans. The labeled amino acids are present in the test meal ingested and incorporated into the blood, representing a single measure of bioavailability. This study aims to develop and apply a new methodology, using stable isotopes, to evaluate the bioavailability of bean protein, a very important food in the Brazilian diet, according to cooking procedures, through the use of deuterium. The project will be divided into two parts: a human nutrition and an agriculture part, the latter by planting/harvesting deuterium-labeled Phaseolus vulgaris L. After two weeks of blooming, deuterium water will be added to the bean crop, which will be subsequently dried. Chemical analysis and assessment of incorporation of deuterium in the beans will be done. Concurrent with the cultivation of beans, there will be a protein absorption test with 15 healthy volunteers for validation of the methods. For comparison purposes, milk protein labeled with deuterium and C13 will be used. The volunteers will consume the test meals. Blood, urine and saliva samples will be collected at baseline (before food ingestion), and in different times after the meal. In the next phase of this research, labeled beans produced by the agriculture experiment will be used to measure the protein absorption of volunteers of different groups (older persons, and stunting and non-stunting children). The samples will analyzed by isotope-ratio mass spectrometry. This methodology may promote a better understanding of the absorption of proteins and amino acids using less invasive methods in different age groups and clinical conditions. This work will have an important impact for the general population as well as for agriculture and health-related professionals.

Conditions

Protein Malabsorption; Nutrition Disorders; Sarcopenia

Keywords

protein availability; beans; children; elderly

Outcome Measures

Primary Outcomes (1)

• Bioavailability protein using deuterium

  Il will be measured new stable isotope method using deuterium for the study of the bioavailability of protein derived from beans in healthy adults, children and elderly. It will be assessed 45 persons, express in delta enrichment and analysis in Mass Spectrometry

  It will be collected for 1 day

Secondary Outcomes (2)

• Bioavailability protein using carbon 13

  It will be collected for 1 day

• Nutritional composition

  through study completion in 1 week

Other Outcomes (1)

• Total urinary nitrogen

  It will be collected for 1 day

Study Arms (3)

adults

Select the individual: 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 and 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. They will eat beans for 5 days. The beans will be soaked for 3 h, water discarded and beans cooked for 20 min in pressure cook. And in the end for the week, adults will be eat the bean enrichment of deuterium for availability protein, collected urine, saliva and blood.

Children

Fifty children will be recruited from ages varying from 1 to 3 years and of both sexes. Children who use medications, who do not habitually consume beans, will be excluded and when there is no explicit written authorization from the parents or guardians. All the children with different status of nutrition will be eaten the beans. They will eat beans for 5 days. The beans will be soaked for 3 h, water discarded and beans cooked for 20 min in pressure cook. And in the end for the week, children will be eat the bean enrichment of deuterium for availability protein, collected urine or saliva depend on the best biological samples of pilot study (adult).

Elderly

Fifty individuals of both sexes will be recruited, previously evaluated by complete clinical / laboratory examination and medical history. The elderly will be excluded from antiinflammatory, chemotherapeutic, corticoid, allergy and bean aversion or antibiotic therapy. These drugs could interfere with protein bioavailability. They will eat beans for 5 days. The beans will be soaked for 3 h, water discarded and beans cooked for 20 min in pressure cook. And in the end for the week, elderly will be eat the bean enrichment of deuterium for availability protein, collected urine or saliva depend on the best biological samples of pilot study (adult).

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

Select healthy person with 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

• Eduardo Ferriolli: lead

Related Publications (3)

• Elango R, Levesque C, Ball RO, Pencharz PB. Available versus digestible amino acids - new stable isotope methods. Br J Nutr. 2012 Aug;108 Suppl 2:S306-14. doi: 10.1017/S0007114512002498.

  PMID: 23107543 BACKGROUND

• Hoffman DJ, Roberts SB, Verreschi I, Martins PA, de Nascimento C, Tucker KL, Sawaya AL. Regulation of energy intake may be impaired in nutritionally stunted children from the shantytowns of Sao Paulo, Brazil. J Nutr. 2000 Sep;130(9):2265-70. doi: 10.1093/jn/130.9.2265.

  PMID: 10958822 BACKGROUND

• Gilani GS. Background on international activities on protein quality assessment of foods. Br J Nutr. 2012 Aug;108 Suppl 2:S168-82. doi: 10.1017/S0007114512002383.

  PMID: 23107528 BACKGROUND

MeSH Terms

Conditions

Nutrition Disorders; Sarcopenia

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Eduardo Ferriolli, PhD

  São Paulo University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Pfrimer, PhD

CONTACT

+551633153370; kpfrimer@fmrp.usp.br

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: April 10, 2018
• Study Start: July 1, 2018
• Primary Completion: August 23, 2018
• Study Completion: December 31, 2020
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share