HealthyNCT03674736
Metabolic Availability of Methionine and Lysine From Rice, Wheat, Chickpea and Lentil in Adult Men
A study testing Dietary Intakes in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The research study is being done so we can determine the quality of the protein present in Rice, Wheat, Chickpeas and Lentils. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). 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
- What is being tested?
- Dietary Intakes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 1 Dec 2022
- 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 (no more than 5 lb weight loss or gain in the past 3 months) 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 Methionine and Lysine From Rice, Wheat, Chickpeas and Lentils, in Healthy Young Adult Men
The research study is being done so we can determine the quality of the protein present in Rice, Wheat, Chickpeas and Lentils. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). Some amino acids are essential which means they must be obtained from the diet. If any one of the essential amino acids is missing in the diet, the body cannot make proteins that are used to repair tissue build bone, teeth, etc… Rice, Wheat, Chickpeas and Lentils as a food source contain low amounts of the essential amino acid methionine (Chickpeas and Lentils) and lysine (Rice and Wheat) which makes its protein incomplete. The amino acids in Rice, Wheat, Chickpeas and Lentils are also affected by cooking. Our objective is to determine the amount of methionine in Rice and Wheat and the amount of lysine in Chickpeas and Lentils that the body can use.
This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of Rice, Wheat, Chickpeas and Lentils as a major protein source in the diet.
Previously the quality of dietary protein for human consumption was studied in animals. This study is being done in humans because studies in animals are not always directly applicable to humans. Plant protein sources like rice, wheat, chickpeas and lentils are important protein sources shown to "enhance ecosystem resilience, and improve human health.
Read the detailed description
If you agree to take part in this study, you will participate in 7 different experiments for each food. For each food you will receive 3 different amounts of Rice, Wheat, Chickpeas or Lentils which will contain different amounts of the essential amino acid methionine (Rice or Wheat) or lysine (Chickpeas or Lentils).
The quality of the protein in the Rice, Wheat, Chickpeas or Lentils will be compared to the quality of a reference protein (egg protein) by giving you 4 reference diets containing amino acids made up like the amino acids in egg protein. The amount of Rice, Wheat, Chickpeas or Lentils you receive will be provided in a random order.
Each experiments will be conduced over 3 days- 2 adaptation days where you will receive the diets at home, provided by the investigators and 1 study day. On the 3rd day (study day) you will visit the Clinical Research Center (CRC) at the Hospital for Sick Children where you will receive 9 hourly meals. Breath samples will be collected after the 4th meal in 15 min intervals for 1 hour. Breath collection will resume again two and a half hours after the 5th meal every 15 minutes until 30 minutes after the last meal. A total of 52 breath samples will be collected during each of the 3rd study day.
Before the study begins, you will visit the CRC at the Hospital for Sick Children for a baseline study assessment. At that time your body composition (fat and fat-free mass) will be measured and your resting energy expenditure will be measured. This will tell us the amount of calories your body need so we can prepare the diets for you for each experiment. This baseline assessment takes about 2 hours.
- Conditions
- Healthy
- Being tested
- Dietary Intakes
- Keywords
- Healthy, Men, Adults, Methionine, Lysine
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary IntakesDietary supplement
Four levels of methionine or lysine intakes will be provided by the reference protein drinks, 3 levels of methionine from rice and wheat bread and 3 levels of lysine from chickpeas and lentils
| Study group | Role | What they receive |
|---|---|---|
| Methionine bioavailability in Rice | Experimental | Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Rice which will be provided by the investigators Receives: Dietary Supplement: Dietary Intakes |
| Lysine bioavailability in Chickpeas | Experimental | Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Chickpeas which will be provided by the investigators Receives: Dietary Supplement: Dietary Intakes |
| Methionine bioavailability in Wheat | Experimental | Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Wheat bread which will be provided by the investigators Receives: Dietary Supplement: Dietary Intakes |
| Lysine bioavailability in Lentils | Experimental | Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Lentils which will be provided by the investigators Receives: Dietary Supplement: Dietary Intakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic availability of Methionine in Rice Apply the IAAO method to determine the MA of methionine in Canadian grown lentils prepared by moist cooking method.
Apply the IAAO method to determine the MA of methionine in rice method.
Measured: 2 years
Metabolic availability of Methionine in Wheat
Apply the IAAO method to determine the MA of methionine in wheat bread
Measured: 2 years
Metabolic availability of Lysine in Chickpeas
Apply the IAAO method to determine the MA of lysine in chickpeas
Measured: 2 years
Metabolic availability of Lysine in Lentils
Apply the IAAO method to determine the MA of lysine in Canadian grown lentils
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 posted17 Sep 2018
- Study start1 Sep 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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 HealthyStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Each subject will randomly receive 4 levels of methionine or lysine provided as free amino acids, Rice, Wheat, Chickpeas or Lentils for a total of 7 studies x 3 days per study.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674736
- Sponsor's protocol ID
- 1000061263
- Status last verified
- May 2023
- First submitted
- 14 Sep 2018
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tul-Noor Z, Paoletti A, Fakiha A, Pencharz PB, Levesque CL, Ball RO, Elango R, Courtney-Martin G. Lysine from Whole Wheat Bread Consumed by Healthy Adult Males Has High Metabolic Availability When Assessed Using the Indicator Amino Acid Oxidation Method. J Nutr. 2025 Feb;155(2):476-482. doi: 10.1016/j.tjnut.2024.08.011. Epub 2024 Aug 18.
PubMed 39163973Fakiha 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 32840580Rafii M, Pencharz PB, Ball RO, Tomlinson C, Elango R, Courtney-Martin G. Bioavailable Methionine Assessed Using the Indicator Amino Acid Oxidation Method Is Greater When Cooked Chickpeas and Steamed Rice Are Combined in Healthy Young Men. J Nutr. 2020 Jul 1;150(7):1834-1844. doi: 10.1093/jn/nxaa086.
PubMed 32271919
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. 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 Methionine and Lysine From Rice, Wheat, Chickpeas and Lentils, in Healthy Young Adult Men
- ClinicalTrials.gov ID
- NCT03674736
- Acronym / sponsor ID
- 1000061263
- Conditions
- Healthy
- Keywords
- Healthy, Men, Adults, Methionine, Lysine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Sep 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 research study is being done so we can determine the quality of the protein present in Rice, Wheat, Chickpeas and Lentils. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). Some amino acids are essential which means they must be obtained from the diet. If any one of the essential amino acids is missing in the diet, the body cannot make proteins that are used to repair tissue build bone, teeth, etc… Rice, Wheat, Chickpeas and Lentils as a food source contain low amounts of the essential amino acid methionine (Chickpeas and Lentils) and lysine (Rice and Wheat) which makes its protein incomplete. The amino acids in Rice, Wheat, Chickpeas and Lentils are also affected by cooking. Our objective is to determine the amount of methionine in Rice and Wheat and the amount of lysine in Chickpeas and Lentils that the body can use.
This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of Rice, Wheat, Chickpeas and Lentils as a major protein source in the diet.
Previously the quality of dietary protein for human consumption was studied in animals. This study is being done in humans because studies in animals are not always directly applicable to humans. Plant protein sources like rice, wheat, chickpeas and lentils are important protein sources shown to "enhance ecosystem resilience, and improve human health.
Detailed description
If you agree to take part in this study, you will participate in 7 different experiments for each food. For each food you will receive 3 different amounts of Rice, Wheat, Chickpeas or Lentils which will contain different amounts of the essential amino acid methionine (Rice or Wheat) or lysine (Chickpeas or Lentils).
The quality of the protein in the Rice, Wheat, Chickpeas or Lentils will be compared to the quality of a reference protein (egg protein) by giving you 4 reference diets containing amino acids made up like the amino acids in egg protein. The amount of Rice, Wheat, Chickpeas or Lentils you receive will be provided in a random order.
Each experiments will be conduced over 3 days- 2 adaptation days where you will receive the diets at home, provided by the investigators and 1 study day. On the 3rd day (study day) you will visit the Clinical Research Center (CRC) at the Hospital for Sick Children where you will receive 9 hourly meals. Breath samples will be collected after the 4th meal in 15 min intervals for 1 hour. Breath collection will resume again two and a half hours after the 5th meal every 15 minutes until 30 minutes after the last meal. A total of 52 breath samples will be collected during each of the 3rd study day.
Before the study begins, you will visit the CRC at the Hospital for Sick Children for a baseline study assessment. At that time your body composition (fat and fat-free mass) will be measured and your resting energy expenditure will be measured. This will tell us the amount of calories your body need so we can prepare the diets for you for each experiment. This baseline assessment takes about 2 hours.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each subject will randomly receive 4 levels of methionine or lysine provided as free amino acids, Rice, Wheat, Chickpeas or Lentils for a total of 7 studies x 3 days per study.
| Arm | Type | Receives |
|---|---|---|
| Methionine bioavailability in Rice | Experimental | Dietary Supplement: Dietary IntakesParticipants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Rice which will be provided by the investigators |
| Lysine bioavailability in Chickpeas | Experimental | Dietary Supplement: Dietary IntakesParticipants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Chickpeas which will be provided by the investigators |
| Methionine bioavailability in Wheat | Experimental | Dietary Supplement: Dietary IntakesParticipants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Wheat bread which will be provided by the investigators |
| Lysine bioavailability in Lentils | Experimental | Dietary Supplement: Dietary IntakesParticipants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Lentils which will 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 (no more than 5 lb weight loss or gain in the past 3 months) 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 |
|---|---|---|
| Dietary IntakesFour levels of methionine or lysine intakes will be provided by the reference protein drinks, 3 levels of methionine from rice and wheat bread and 3 levels of lysine from chickpeas and lentils | Dietary supplement | Lysine bioavailability in Chickpeas, Lysine bioavailability in Lentils, Methionine bioavailability in Rice, Methionine bioavailability in Wheat |
Primary outcome
Metabolic availability of Methionine in Rice Apply the IAAO method to determine the MA of methionine in Canadian grown lentils prepared by moist cooking method.
Time frame: 2 years
Apply the IAAO method to determine the MA of methionine in rice method.
Metabolic availability of Methionine in Wheat
Time frame: 2 years
Apply the IAAO method to determine the MA of methionine in wheat bread
Metabolic availability of Lysine in Chickpeas
Time frame: 2 years
Apply the IAAO method to determine the MA of lysine in chickpeas
Metabolic availability of Lysine in Lentils
Time frame: 2 years
Apply the IAAO method to determine the MA of lysine in Canadian grown lentils
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 2 Jun 2023.
- Derived from this study: PubMed 39163973Tul-Noor Z, Paoletti A, Fakiha A, Pencharz PB, Levesque CL, Ball RO, Elango R, Courtney-Martin G. Lysine from Whole Wheat Bread Consumed by Healthy Adult Males Has High Metabolic Availability When Assessed Using the Indicator Amino Acid Oxidation Method. J Nutr. 2025 Feb;155(2):476-482. doi: 10.1016/j.tjnut.2024.08.011. Epub 2024 Aug 18.
- 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.
- Derived from this study: PubMed 32271919Rafii M, Pencharz PB, Ball RO, Tomlinson C, Elango R, Courtney-Martin G. Bioavailable Methionine Assessed Using the Indicator Amino Acid Oxidation Method Is Greater When Cooked Chickpeas and Steamed Rice Are Combined in Healthy Young Men. J Nutr. 2020 Jul 1;150(7):1834-1844. doi: 10.1093/jn/nxaa086.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 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 Dietary Intakes in people with Healthy, 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 2 Jun 2023. 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 Methionine in Rice Apply the IAAO method to determine the MA of methionine in Canadian grown lentils prepared by moist cooking method. (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT03674736, 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 2 Jun 2023.