Healthy Clinical Trial
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
| NCT number | NCT03110913 |
| Other study ID # | 1000056244 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 1, 2017 |
| Est. completion date | May 1, 2019 |
| Verified date | October 2019 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The research study is being done so we can determine the quality of the protein present in
Canadian 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… Lentils as a
food source contain low amounts of the essential amino acid methionine which makes its
protein incomplete. The amino acids in lentils are also affected by cooking. Our objective is
to determine the amount of methionine in lentils that the body can use. We will test lentils
by studying them after cooking them in a stew, on their own and by combining the lentil stew
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 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 directly applicable to
humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant
protein sources like lentils are important alternatives shown to "enhance ecosystem
resilience, and improve human health.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | May 1, 2019 |
| Est. primary completion date | May 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 49 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Metabolic availability of methionine in Canadian lentils | Apply the IAAO method to determine the MA of methionine in Canadian grown lentils prepared by moist cooking method. | 2 years |
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