Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic Availability of Methionine and Lysine From Rice, Wheat, Chickpea and Lentil in Adult Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674736
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Dietary Intakes Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methionine bioavailability in Rice
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
Dietary Supplement: Dietary Intakes
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

Experimental: Lysine bioavailability in Chickpeas
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
Dietary Supplement: Dietary Intakes
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

Experimental: Methionine bioavailability in Wheat
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
Dietary Supplement: Dietary Intakes
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

Experimental: Lysine bioavailability in Lentils
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
Dietary Supplement: Dietary Intakes
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




Primary Outcome Measures :
  1. 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.

  2. Metabolic availability of Methionine in Wheat [ Time Frame: 2 years ]
    Apply the IAAO method to determine the MA of methionine in wheat bread

  3. Metabolic availability of Lysine in Chickpeas [ Time Frame: 2 years ]
    Apply the IAAO method to determine the MA of lysine in chickpeas

  4. Metabolic availability of Lysine in Lentils [ Time Frame: 2 years ]
    Apply the IAAO method to determine the MA of lysine in Canadian grown lentils



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674736


Contacts
Layout table for location contacts
Contact: mahroukh Rafii, BSc. 4168137454 mahroukh.rafii@sickkids.ca

Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Mahroukh Rafii, BSc.    4168137454    mahroukh.rafii@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Glenda Courtney-Martin, Project Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03674736    
Other Study ID Numbers: 1000061263
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenda Courtney-Martin, The Hospital for Sick Children:
Healthy
Men
Adults
Methionine
Lysine