CompletedNot Applicable

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

Lebanon16 participantsStarted 2019-02-06

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

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Inclusion Criteria: * Efforts will be made to age and gender match subjects (balanced number of males and females in each group). Subjects are appropriate if they are in the age range between 18 and 60. Women who are in the reproductive age will be studied at the first half of their menstrual cycle, because estrogen is known to affect the energy expenditure. Postmenopausal women taking hormonal replacement therapy will be excluded. Subjects should have: Cr \<1mg/dl for women and \<1.2mg/dl for men and GFR \>60 ml/min/1.73m2. Exclusion Criteria: * Subjects with diabetes, cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrinological (PTH), or any significant medical disease will be excluded. * Pregnant and lactating women. * Subjects on regular use of medication that affects body weight and/or having a weight loss of 3% or more in the preceding 3 months. * Subjects with: Cr \>1mg/dl for women and \>1.2mg/dl for men and GFR\<60 ml/min/1.73m2.

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postprandial glycemia

Timeframe: 120 min

Energy expenditure

Timeframe: 240 min

Trial details

NCT IDNCT03836495

SponsorAmerican University of Beirut Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-10

View on ClinicalTrials.gov More Postprandial Hyperglycemia trials