Clinical Trials Logo

Clinical Trial Summary

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries.

As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of millet protein in humans on which nutrition recommendations can be built.


Clinical Trial Description

Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.

4 reference diet would be based on egg protein composition, 3 millet diets would have protein from cooked millet and 1 mixed meal would comprise of cooked millet and lentils.

Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.

For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.

Measurements:

Resting energy expenditure (REE) will be measured by open-circuit indirect calorimetry Body composition (fat and fat free mass) will be measured by BIA and Skin Fold. Breath samples will be collected after the 4th and 7th meals. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03339167
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Completed
Phase N/A
Start date November 11, 2017
Completion date January 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT02575209 - Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects N/A
Completed NCT00900107 - Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals N/A
Completed NCT02517775 - Effects of Cranberry Consumption in Vascular Function in Healthy Individuals N/A
Active, not recruiting NCT03298373 - 28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men Phase 1
Completed NCT01710280 - Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia N/A
Completed NCT01130948 - Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects N/A
Completed NCT01382069 - Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men Phase 1
Recruiting NCT05523674 - Effects of Warm-up Intensity and Blood Flow Restriction N/A
Not yet recruiting NCT05865574 - A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection Phase 1
Completed NCT01296997 - Calcium Phosphate and Incretins N/A
Completed NCT01293591 - Garlic Intake And Biomarkers Of Cancer Risk N/A
Completed NCT00935662 - A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses Phase 1
Completed NCT01221558 - Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men Phase 3
Active, not recruiting NCT05825781 - Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man Phase 1
Completed NCT02994602 - Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males Phase 1
Completed NCT02365987 - The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety N/A
Completed NCT02072278 - Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects Phase 1
Completed NCT02093169 - D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound Phase 1
Completed NCT03411005 - Metabolic Availability of Lysine From Sorghum in Adult Men N/A
Recruiting NCT02927210 - Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015) Phase 1