Protein MalabsorptionNCT03492190
Bioavailability of Proteins From Plant Based Diets
An observational study of Protein Malabsorption and Nutrition Disorders, run by Eduardo Ferriolli.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Malabsorption, Nutrition Disorders, Sarcopenia
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Select healthy person with inclusion criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bioavailability of Proteins From Beans Usually Consumed in the Brazilian Diet (Phaseolus Vulgaris) According to Different Preparation Techniques.
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.
Read the detailed description
This study is divided in 4 phase. First Phase: Agriculture (Year 1) Site description: The experiment will carried out at the Experimental Farm of São Paulo's Agency for Agribusiness Technology (APTA) in Ribeirao Preto, Brazil, at the geographic coordinates of 21°12'26" S e 47°51'48" N and average altitude of 646 m. The annual rainfall is about 1427 mm, with average maximum and minimum temperature of 25°C and 19.3°C, respectively. The soil is classified as Oxitol with glay texture. The bean crop (Phaseolus vulgaris), will be grown at the 0,50m between rows with 12 seed per linear meters and at the 2 weeks after anthesis (flowering) the water supply will be amended with deuterium oxide to experimental development. The grain produced will be harvested to experimental analysis and consumption. The experimental area will have 5.000 m2 with common bean crop to produce enough quantity of grains to the experiment running. Seeds will be dried in a scale of 1 to 10 kg of dry and selected seeds.
Nutrients Composition Analysis (Year 1) Six samples of 100g each will be separated for nutrients composition analyses, that will be performed at the Animal Nutrition Laboratory of the Animal Science Institute of the University of São Paulo, Brazil. Right after harvesting, the food samples will be weighted and dried in a stove with forced air circulation at 65 degrees Celsius, during 72 hours. After this, samples will be ground in a mill with 2 mm hole sieve, and a subsample will be taken for the analysis of dry mass, protein, ether extract, mineral mass, energy, calcium and phosphorus, according to Official Methods of Analysis (AOAC) (1996). Fibre will be analysed in neutral and acid detergent according to reference Silva and Queiroz, 2005, and selenium will be analysed according to Olson et al., 1975. Energy analysis will be performed by a calorimetric bomb and fat by the extraction according to reference Bligh and Dyer, 1959, at the Nutrients Composition Laboratory of the Ribeirão Preto Medical School.
Second phase (pilot study), Nutrition Institute (Year 2) Subjects Fifteen adult volunteers will be recruited for method validation. 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 Study design After approval of project by local ethics committee and obtaining signed informed consent, volunteers will be offered a test meal with milk protein. The test protein in the first place will be whole milk protein, produced with a low level deuterium enrichment within the study. This will permit the Carbon-13 single cell protein to be characterised against a well-studied animal protein known to possess high digestibility. Tracer Amino Acid (AA) appearance in the circulation (blood; saliva, urine and breath will also be sampled) and the relative appearance of test and reference protein will be taken as a measure of relative bioavailability which can be converted into an absolute measure once the reference protein has been characterised. The basic measurement will be of stable isotope enrichment in individual amino acids.
Phase 1 pilot study, Nutrition Institute. Fifteen adult volunteers will be recruited for method validation.
Third Phase is in 15 children (1-3 years, with different nutritional status) and Fourth phase is in 15 elderly (more than 65 years, with sarcopenia or not sarcopenia).
Test meal 1: Beans soaked for 3 h, water discarded and beans cooked for 20 min in pressure cook.
The test meal will be separated by the use for two weeks of unlabelled beans. The same approach as used in the pilot study of milk protein will be adopted to study the bioavailability of grain legumes through simultaneous comparison with a modest quantity carbon-13 enriched single cell protein combined in the same test meal.
All groups will be analysed food intake assessment, total urinary nitrogen and enrichment of deuterium in protein. Four 24h Recall Questionnaires will be applied to each volunteer during the periods of intake of the test meal, in order to verify the protein and calories consumption. Volunteers will be asked to keep their usual intake, to avoid changes in food consumption. Total urinary nitrogen of the samples will be analysed by the Kjeldahl method with ammonium micro diffusion. Compound specific isotope enrichment in amino acids will be analysed in saliva, urine, breath and blood samples. Carbon-13 in breath carbon dioxide (CO2) and Deuterium in urine enrichment will be analysed in Mass Spectrometry of Medicine School of Ribeirão Preto (FMRP-USP), Brazil, SP.
- Conditions
- Protein Malabsorption, Nutrition Disorders, Sarcopenia
- Keywords
- protein availability, beans, children, elderly
- Medical subject headings
- Nutrition Disorders, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: It will be collected for 1 day
Secondary outcomes (2)
Bioavailability protein using carbon 13
Il will be measured stable isotope using Carbon 13 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
Measured: It will be collected for 1 day
Nutritional composition
3 samples for beans cooked will be collected and will be verified the nutrients composition properties of the usually consumed Brazilian bean (Phaseolus vulgaris) labelled with deuterium like macronutrients and micronutrients in grams.
Measured: through study completion in 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Jul 2018 (estimated)
- Primary completion23 Aug 2018 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Protein MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduardo Ferriolli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Ferriolli, University of Sao Paulo
- Investigators
- Eduardo Ferriolli, PhD, Principal investigator, São Paulo University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492190
- Sponsor's protocol ID
- 2207
- Status last verified
- May 2018
- First submitted
- 23 Feb 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make this data available to other researchers. We will publish this data in the scientific magazine
Publications
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.
PubMed 23107543Hoffman 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.
PubMed 10958822Gilani 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.
PubMed 23107528
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Proteins From Beans Usually Consumed in the Brazilian Diet (Phaseolus Vulgaris) According to Different Preparation Techniques.
- ClinicalTrials.gov ID
- NCT03492190
- Acronym / sponsor ID
- 2207
- Conditions
- Protein Malabsorption, Nutrition Disorders, Sarcopenia
- Keywords
- protein availability, beans, children, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Eduardo FerriolliUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 23 Aug 2018 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is divided in 4 phase. First Phase: Agriculture (Year 1) Site description: The experiment will carried out at the Experimental Farm of São Paulo's Agency for Agribusiness Technology (APTA) in Ribeirao Preto, Brazil, at the geographic coordinates of 21°12'26" S e 47°51'48" N and average altitude of 646 m. The annual rainfall is about 1427 mm, with average maximum and minimum temperature of 25°C and 19.3°C, respectively. The soil is classified as Oxitol with glay texture. The bean crop (Phaseolus vulgaris), will be grown at the 0,50m between rows with 12 seed per linear meters and at the 2 weeks after anthesis (flowering) the water supply will be amended with deuterium oxide to experimental development. The grain produced will be harvested to experimental analysis and consumption. The experimental area will have 5.000 m2 with common bean crop to produce enough quantity of grains to the experiment running. Seeds will be dried in a scale of 1 to 10 kg of dry and selected seeds.
Nutrients Composition Analysis (Year 1) Six samples of 100g each will be separated for nutrients composition analyses, that will be performed at the Animal Nutrition Laboratory of the Animal Science Institute of the University of São Paulo, Brazil. Right after harvesting, the food samples will be weighted and dried in a stove with forced air circulation at 65 degrees Celsius, during 72 hours. After this, samples will be ground in a mill with 2 mm hole sieve, and a subsample will be taken for the analysis of dry mass, protein, ether extract, mineral mass, energy, calcium and phosphorus, according to Official Methods of Analysis (AOAC) (1996). Fibre will be analysed in neutral and acid detergent according to reference Silva and Queiroz, 2005, and selenium will be analysed according to Olson et al., 1975. Energy analysis will be performed by a calorimetric bomb and fat by the extraction according to reference Bligh and Dyer, 1959, at the Nutrients Composition Laboratory of the Ribeirão Preto Medical School.
Second phase (pilot study), Nutrition Institute (Year 2) Subjects Fifteen adult volunteers will be recruited for method validation. 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 Study design After approval of project by local ethics committee and obtaining signed informed consent, volunteers will be offered a test meal with milk protein. The test protein in the first place will be whole milk protein, produced with a low level deuterium enrichment within the study. This will permit the Carbon-13 single cell protein to be characterised against a well-studied animal protein known to possess high digestibility. Tracer Amino Acid (AA) appearance in the circulation (blood; saliva, urine and breath will also be sampled) and the relative appearance of test and reference protein will be taken as a measure of relative bioavailability which can be converted into an absolute measure once the reference protein has been characterised. The basic measurement will be of stable isotope enrichment in individual amino acids.
Phase 1 pilot study, Nutrition Institute. Fifteen adult volunteers will be recruited for method validation.
Third Phase is in 15 children (1-3 years, with different nutritional status) and Fourth phase is in 15 elderly (more than 65 years, with sarcopenia or not sarcopenia).
Test meal 1: Beans soaked for 3 h, water discarded and beans cooked for 20 min in pressure cook.
The test meal will be separated by the use for two weeks of unlabelled beans. The same approach as used in the pilot study of milk protein will be adopted to study the bioavailability of grain legumes through simultaneous comparison with a modest quantity carbon-13 enriched single cell protein combined in the same test meal.
All groups will be analysed food intake assessment, total urinary nitrogen and enrichment of deuterium in protein. Four 24h Recall Questionnaires will be applied to each volunteer during the periods of intake of the test meal, in order to verify the protein and calories consumption. Volunteers will be asked to keep their usual intake, to avoid changes in food consumption. Total urinary nitrogen of the samples will be analysed by the Kjeldahl method with ammonium micro diffusion. Compound specific isotope enrichment in amino acids will be analysed in saliva, urine, breath and blood samples. Carbon-13 in breath carbon dioxide (CO2) and Deuterium in urine enrichment will be analysed in Mass Spectrometry of Medicine School of Ribeirão Preto (FMRP-USP), Brazil, SP.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Select healthy person with inclusion criteria
Key inclusion criteria (5 listed)
- Healthy, non-pregnant adults 18-65 years of age
Key exclusion criteria (6 listed)
- Children and elderly (over 65)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bioavailability protein using deuterium
Time frame: It will be collected for 1 day
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
2 secondary outcomes
Bioavailability protein using carbon 13
Time frame: It will be collected for 1 day
Nutritional composition
Time frame: through study completion in 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 23107543Elango 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.
- Background: PubMed 10958822Hoffman 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.
- Background: PubMed 23107528Gilani 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.
- Individual participant dataSharing planned: No. There is no plan to make this data available to other researchers. We will publish this data in the scientific magazine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Ferriolli, PhD principal investigator
São Paulo University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Protein Malabsorption and Nutrition Disorders, run by Eduardo Ferriolli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina Pfrimer, PhD (+551633153370, kpfrimer@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability protein using deuterium (time frame: It will be collected for 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492190, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.