Metabolic Availability of Methionine From Chickpeas in Adult Men

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT03339154

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The research study is being done so we can determine the quality of the protein present in Canadian chickpeas. 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…Chickpeas as a food source contain low amounts of the essential amino acid methionine which makes its protein incomplete. The amino acids in chickpeas are also affected by cooking. Our objective is to determine the amount of methionine in chickpeas that the body can use. We will test chickpeas by studying them after cooking them, on their own and by combining the chickpeas with rice in a mixed meal to make a more complete protein.

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 chickpeas 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 directly applicable to humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant protein sources like chickpeas are important alternatives shown to "enhance ecosystem resilience, and improve human health.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Dietary Intakes	N/A

Detailed Description

If you agree to take part in this study, you will receive 3 different amounts of chickpeas which will contain different amounts of the essential amino acid methionine as well as 3 different amount of chickpeas complemented with rice. The chickpeas will be cooked on its own or served with the rice. The quality of the protein in the chickpeas will be compared to the quality of a reference protein (egg protein) by giving you 4 reference diets containing amino acids make up like the amino acids in egg protein. The amount of chickpeas you receive will be provided in a random order.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each subject will randomly receive 4 levels of methionine provided as free amino acids, chickpeas, or chickpeas combined with rice for a total of 10 studies x 3 days per study.Each subject will randomly receive 4 levels of methionine provided as free amino acids, chickpeas, or chickpeas combined with rice for a total of 10 studies x 3 days per study.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Study Title: Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Methionine From Canadian Lentils, in Healthy Young Adult Men

Actual Study Start Date :

Aug 4, 2017

Actual Primary Completion Date :

Aug 4, 2018

Actual Study Completion Date :

Sep 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methionine bioavailability in chickpeas Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 10 times. levels of phenylalanine intake (7 Study periods). You could be expected to participate in up to 10 different sets of experiments which will take 11 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 with or without rice, which will be provided by the investigators	Other: Dietary Intakes Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from chickpeas and 3 levels from chickpeas with rice.

Arm

Intervention/Treatment

Experimental: Methionine bioavailability in chickpeas

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 10 times. levels of phenylalanine intake (7 Study periods). You could be expected to participate in up to 10 different sets of experiments which will take 11 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 with or without rice, which will be provided by the investigators

Other: Dietary Intakes

Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from chickpeas and 3 levels from chickpeas with rice.

Outcome Measures

Primary Outcome Measures

Metabolic availability of methionine in Canadian chickpeas [2 years]
Apply the IAAO method to determine the MA of methionine in Canadian grown chickpeas prepared by moist cooking method.

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

None specified.

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:

NCT03339154

Other Study ID Numbers:

1000056462

First Posted:

Nov 13, 2017

Last Update Posted:

Nov 13, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Glenda Courtney-Martin, Project Investigator, The Hospital for Sick Children

Study Results

No Results Posted as of Nov 13, 2018