Healthy MenNCT03339167
Metabolic Availability of Lysine From Millet in Adult Men
A study testing Metabolic availability of lysine in millet in people with Healthy Men, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- Metabolic availability of lysine in millet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2017to 31 Jan 2019
- Phase
- Interventional
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, age 18 - 49 yrs Healthy, with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes Stable Body Weight Not on any medications that could affect protein or amino acid metabolism e.g. steroids
Who cannot join
- Unwillingness to participate or unable to tolerate the diet Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Millet Protein, in Young Adult Men
Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries.
As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of millet protein in humans on which nutrition recommendations can be built.
Read the detailed description
Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.
4 reference diet would be based on egg protein composition, 3 millet diets would have protein from cooked millet and 1 mixed meal would comprise of cooked millet and lentils.
Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.
For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.
Measurements:
Resting energy expenditure (REE) will be measured by open-circuit indirect calorimetry Body composition (fat and fat free mass) will be measured by BIA and Skin Fold. Breath samples will be collected after the 4th and 7th meals.
- Conditions
- Healthy Men
- Being tested
- Metabolic availability of lysine in millet
- Keywords
- Lysine, Adult, Protein Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic availability of lysine in milletDietary supplement
Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from millet and 1 level from millet with lentils.
| Study group | Role | What they receive |
|---|---|---|
| metabolic availability of lysine in millet | Experimental | Participants will be seen initially for pre-study assessment (2 hour). They will then be studied at 8 levels of lysine intake.
Subjects will visit SickKid's Clinical Research Center a total of 9 times, with each visit being at least one week before the next. All 9 visits must be made within 6 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked millet with or without lentils, which will all be provided by the investigators. Receives: Dietary Supplement: Metabolic availability of lysine in millet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic availability of Lysine in millet
Apply the IAAO method to determine the Metabolic availability of Lysine in millet prepared by wet heat cooking method.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start11 Nov 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject will randomly receive 3 levels of lysine provided as free amino acids, millet, or millet combined with lentils for a total of 8 studies x 3 days per study.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, BSc, MSc, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339167
- Sponsor's protocol ID
- 1000057921
- Status last verified
- Apr 2019
- First submitted
- 8 Nov 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fakiha A, Tul-Noor Z, Paoletti A, Pencharz PB, Ball RO, Levesque CL, Elango R, Courtney-Martin G. Bioavailable Lysine, Assessed in Healthy Young Men Using Indicator Amino Acid Oxidation, is Greater when Cooked Millet and Stewed Canadian Lentils are Combined. J Nutr. 2020 Oct 12;150(10):2729-2737. doi: 10.1093/jn/nxaa227.
PubMed 32840580
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Millet Protein, in Young Adult Men
- ClinicalTrials.gov ID
- NCT03339167
- Acronym / sponsor ID
- 1000057921
- Conditions
- Healthy Men
- Keywords
- Lysine, Adult, Protein Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Nov 2017 (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.
Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries.
As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of millet protein in humans on which nutrition recommendations can be built.
Detailed description
Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.
4 reference diet would be based on egg protein composition, 3 millet diets would have protein from cooked millet and 1 mixed meal would comprise of cooked millet and lentils.
Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.
For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.
Measurements:
Resting energy expenditure (REE) will be measured by open-circuit indirect calorimetry Body composition (fat and fat free mass) will be measured by BIA and Skin Fold. Breath samples will be collected after the 4th and 7th meals.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject will randomly receive 3 levels of lysine provided as free amino acids, millet, or millet combined with lentils for a total of 8 studies x 3 days per study.
| Arm | Type | Receives |
|---|---|---|
| metabolic availability of lysine in millet | Experimental | Dietary Supplement: Metabolic availability of lysine in milletParticipants will be seen initially for pre-study assessment (2 hour). They will then be studied at 8 levels of lysine intake. Subjects will visit SickKid's Clinical Research Center a total of 9 times, with each visit being at least one week before the next. All 9 visits must be made within 6 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked millet with or without lentils, which will all be provided by the investigators. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male, age 18 - 49 yrs Healthy, with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes Stable Body Weight Not on any medications that could affect protein or amino acid metabolism e.g. steroids
Key exclusion criteria (1 listed)
- Unwillingness to participate or unable to tolerate the diet Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic availability of lysine in milletFour levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from millet and 1 level from millet with lentils. | Dietary supplement | metabolic availability of lysine in millet |
Primary outcome
Metabolic availability of Lysine in millet
Time frame: 2 years
Apply the IAAO method to determine the Metabolic availability of Lysine in millet prepared by wet heat cooking method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Derived from this study: PubMed 32840580Fakiha A, Tul-Noor Z, Paoletti A, Pencharz PB, Ball RO, Levesque CL, Elango R, Courtney-Martin G. Bioavailable Lysine, Assessed in Healthy Young Men Using Indicator Amino Acid Oxidation, is Greater when Cooked Millet and Stewed Canadian Lentils are Combined. J Nutr. 2020 Oct 12;150(10):2729-2737. doi: 10.1093/jn/nxaa227.
- Individual participant dataSharing planned: No
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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.
Glenda Courtney-Martin, BSc, MSc, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic availability of lysine in millet in people with Healthy Men, run by The Hospital for Sick Children at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic availability of Lysine in millet (time frame: 2 years). 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 NCT03339167, which also lists 1 linked publication.
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 8 Apr 2019.