NCT03836495

The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis

Completed NA Last updated 6 October 2025

What this trial tests

NA trial testing lysine and phosphorus in Postprandial Hyperglycemia in 16 participants. Completed in 20 May 2020.

Timeline

6 February 2019

Primary endpoint
10 May 2020

20 May 2020

Quick facts

Lead sponsor	American University of Beirut Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	16
Start date	6 February 2019
Primary completion	10 May 2020
Estimated completion	20 May 2020
Sites	1 location across Lebanon

Drugs / interventions tested

• lysine and phosphorus

Conditions studied

• Postprandial Hyperglycemia — all drugs for Postprandial Hyperglycemia →
• Energy Expenditure — all drugs for Energy Expenditure →

Sponsor

American University of Beirut Medical Center

Who can join

Adults 18 to 60, any sex, with Postprandial Hyperglycemia or Energy Expenditure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Wheat and wheat derived products are highly consumed around the world. They constitute the major dietary source of protein and energy for many individuals. Wheat contains moderate quantity of low quality protein lacking in some essential amino acids, primarily lysine, thus wheat based diets can't sustain optimal growth, and accordingly should be supplemented with lysine or complemented by another protein source of better quality to match human needs. However, human studies showed that wheat flour fortification with lysine was able to slightly improve growth, namely by increasing weight gain, but it did not however completely reverse growth impairment provoked by the consumption of wheat-based diets.

The investigators developed interest in the role of phosphorus in health and diseased and believe that the modest impact of lysine fortification may due to low phosphorus availability of wheat products. Phosphorus content of cereals is mainly in the form of phytate that is not bioavailable. Supplementing a wheat gluten based diet with a combination of lysine and phosphorus was able to highly amplify the increase in weight gain and energy efficiency of rats as compared to lysine or phosphorus supplementation alone. Phosphorus is an essential mineral known to be directly involved in the production of ATP, which is essential for many metabolic processes including protein synthesis.

The investigators believe that a better approach to enhance the quality of a wheat-based diet is through the supplementation with a combination of both lysine and phosphorus.

The present study is designed to investigate the effect of white flour fortification with lysine and/or phosphorus on sensory properties, postprandial glycaemia and insulinemia, as well as postprandial thermogenesis.

Most specifically, we aim to:

1. Determine the acceptability and assess sensory differences of the fortified breads.
2. Determine the glycemic response after ingestion of the different fortified breads.
3. Evaluate the variation in energy expenditure after the consumption of the fortified breads.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.