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

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Recruiting
CT.gov ID
NCT03674736
Collaborator
(none)
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1
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Study Details

Study Description

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
  • Dietary Supplement: Dietary Intakes
N/A

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

Study Type:
Interventional
Anticipated 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.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 :
Sep 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

Outcome Measures

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. [2 years]

    Apply the IAAO method to determine the MA of methionine in rice method.

  2. Metabolic availability of Methionine in Wheat [2 years]

    Apply the IAAO method to determine the MA of methionine in wheat bread

  3. Metabolic availability of Lysine in Chickpeas [2 years]

    Apply the IAAO method to determine the MA of lysine in chickpeas

  4. Metabolic availability of Lysine in Lentils [2 years]

    Apply the IAAO method to determine the MA of lysine in Canadian grown lentils

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Glenda Courtney-Martin, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glenda Courtney-Martin, Project Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT03674736
Other Study ID Numbers:
  • 1000061263
First Posted:
Sep 17, 2018
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Glenda Courtney-Martin, Project Investigator, The Hospital for Sick Children

Study Results

No Results Posted as of Oct 19, 2021