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

NCT03836495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-10-06

No results posted yet for this study

Summary

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.

Conditions

  • Postprandial Hyperglycemia
  • Energy Expenditure

Interventions

DIETARY_SUPPLEMENT

lysine and phosphorus

addition of lysine and essential amino acid and/or phosphorus an essential mineral

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Omar Obeid, PhD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2020-05-10
Completion
2020-05-20

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836495 on ClinicalTrials.gov