Postprandial HyperglycemiaNCT03836495
The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis
A study testing lysine and phosphorus in people with Postprandial Hyperglycemia and Energy Expenditure, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Energy Expenditure
- What is being tested?
- lysine and phosphorus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteLebanon
- Study dates
- 6 Feb 2019to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- Determine the acceptability and assess sensory differences of the fortified breads.
- Determine the glycemic response after ingestion of the different fortified breads.
- Evaluate the variation in energy expenditure after the consumption of the fortified breads.
Read the detailed description
Specific Aim 1: Determine the acceptability and assess sensory differences of the fortified breads.
White wheat flour will be fortified with either lysine, phosphorus, or both lysine and phosphorus. The acceptability of these fortified breads will be tested.
L- Lysine monohydrochloride will be used as the sources of lysine. Potassium phosphate will be used as the source of phosphorus. From previous experience, the addition of potassium phosphate to glucose solution was found to minimally affect the organoleptic properties. Unlike that of sodium phosphate that was not well tolerated by subjects due to development of unfavorable flavor (fishy flavor).
Locally produced white wheat flour (80% extraction) will be purchased and stored at the department. White flour samples will be analyzed for their content of phosphorus according to standard procedures.
Fortification:
Fortification with lysine: 625mg of L-lysine monohydrochloride will be added to 100g of wheat flour, giving a fortification rate of 500mg of lysine (0.5%) in 100g of wheat flour.
Fortification with phosphorus: Phosphorus will be added to white wheat flour in the proportion of 500mg of phosphorus in 100g of white wheat flour, and this will add up to a total of 608mg of phosphorus in 100g of fortified white wheat flour (with 108mg of phosphorus initially present in 100g of unfortified white wheat flour).
Making of breads:
Four different types of bread will be made:
White bread unfortified (WB) White bread fortified with lysine (WB-L) White bread fortified with phosphorus (WB-P) White bread fortified with lysine and phosphorus (WB-LP)
Acceptability of the four different breads:
Bread samples will be tested for acceptability. Panelists (n= 60) will be recruited based on their willingness to participate in the study and their consumption of Arabic bread.
Panelists will be asked to fill a questionnaire and to rate the served samples on a 9-point hedonic scale with 1 representing dislike extremely and 9 representing like extremely for overall acceptability, acceptability of appearance, texture and taste. The order of presentation of the samples will be counterbalanced.
Sensory evaluation of the four different breads:
Panelists (n=24) who are regular consumers of white bread will be recruited to assess any sensory differences between experimental samples of the white bread control and the three white breads supplemented with lysine and/or phosphorus. The triangle test will be used in the difference tests.
All subjects will be asked to sign human subjects consent forms and answer demographic information. Demographic information that will be requested will be: 1) age, 2) gender, 3) frequency of bread consumption, 4) type of bread typically consumed, and 5) what factors influence the panelists' bread purchase.
Twenty four panelists will participate in three triangle test, comparing the white bread control vs. each of the three experimental samples in each test. In the session, subjects will be debriefed about a) the products they will consume, b) the procedures for the testing, c) instructions on how to sample the beverages, and d) how to use the score card. All samples will be presented in a random, balanced order.
Mineral and carbohydrate content of bread:
Phosphorus content of the breads will be determined.
Specific Aim 2: Determine the glycemic response following the consumption of the different fortified breads.
In this experiment, healthy subjects (n=12) will be recruited and asked to maintain their regular dietary and physical activity habits during the entire study course, avoid alcohol consumption as well as any unusual strenuous exercise 24 hours prior to the study.
Exclusion criteria: any significant medical diseases; pregnancy or lactation; regular use of medication that affects body weight; a weight loss of 3% or more in the preceding 3 months.
Following a 12 hour (overnight) fast, subjects will be taken to the testing facility [Faculty of Agriculture and Food Sciences/Department of Nutrition or the Central research unit (CRU)/ American University Hospital] where anthropometric measurements (height, weight) will be taken. A catheter will be inserted for blood withdrawal.
Postprandial glycemic response after consumption of the four fortified breads will be determined.
A crossover design will be used in which each subject will undertake 4 visits in a random order over 4 different days, the difference between the visits being the type of bread to be consumed.
In brief, overnight fasted subjects will be given the bread (50 g of carbohydrate) to ingest within 10-15 min and drink 250 ml of water. Blood samples will be taken immediately before the meal and at 15, 30, 45, 60, 90 and 120 minutes after meal ingestion. Blood will be withdrawn by a trained practitioner and will be used for the determination of glucose.
Glucose area under the curve (AUC) will be calculated. In addition, mineral and several metabolites content of the blood will be measured (glucose, total phosphorus, triglycerides, insulin and GLP-1).
Specific Aim 3: Evaluate the variation in Energy Expenditure after the consumption of the fortified breads.
Subject recruitment: 16 healthy subjects in total will be recruited. 14 subjects will be required in order to be able to detect significance at the level of 0.05, using a 25% difference between treatments and 90% power. But, a total number of 16 subjects will be recruited in order to allow for the loss which might take place due to the dropping out.
Inclusion criteria: 16 subjects (BMI between 20 and 25) will be recruited. 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.
- Conditions
- Postprandial Hyperglycemia, Energy Expenditure
- Being tested
- lysine and phosphorus
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lysine and phosphorusDietary supplement
addition of lysine and essential amino acid and/or phosphorus an essential mineral
| Study group | Role | What they receive |
|---|---|---|
| White bread unfortified (WB) | Experimental | bread with no lysine no phosphorus Receives: Dietary Supplement: lysine and phosphorus |
| White bread fortified with lysine (WB-L) | Experimental | Bread with lysine Receives: Dietary Supplement: lysine and phosphorus |
| White bread fortified with phosphorus (WB-P) | Experimental | bread with phosphorus Receives: Dietary Supplement: lysine and phosphorus |
| White bread fortified with lysine and phosphorus (WB-LP) | Experimental | Bread with phosphorus and lysine Receives: Dietary Supplement: lysine and phosphorus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemia
postprandial blood glucose level
Measured: 120 min
Energy expenditure
Postprandial energy expenditure
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start6 Feb 2019
- Primary completion10 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Obeid, American University of Beirut Medical Center
- Investigators
- Omar Obeid, PhD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836495
- Sponsor's protocol ID
- BIO-2017-0278
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis
- ClinicalTrials.gov ID
- NCT03836495
- Acronym / sponsor ID
- BIO-2017-0278
- Conditions
- Postprandial Hyperglycemia, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the acceptability and assess sensory differences of the fortified breads.
- Determine the glycemic response after ingestion of the different fortified breads.
- Evaluate the variation in energy expenditure after the consumption of the fortified breads.
Detailed description
Specific Aim 1: Determine the acceptability and assess sensory differences of the fortified breads.
White wheat flour will be fortified with either lysine, phosphorus, or both lysine and phosphorus. The acceptability of these fortified breads will be tested.
L- Lysine monohydrochloride will be used as the sources of lysine. Potassium phosphate will be used as the source of phosphorus. From previous experience, the addition of potassium phosphate to glucose solution was found to minimally affect the organoleptic properties. Unlike that of sodium phosphate that was not well tolerated by subjects due to development of unfavorable flavor (fishy flavor).
Locally produced white wheat flour (80% extraction) will be purchased and stored at the department. White flour samples will be analyzed for their content of phosphorus according to standard procedures.
Fortification:
Fortification with lysine: 625mg of L-lysine monohydrochloride will be added to 100g of wheat flour, giving a fortification rate of 500mg of lysine (0.5%) in 100g of wheat flour.
Fortification with phosphorus: Phosphorus will be added to white wheat flour in the proportion of 500mg of phosphorus in 100g of white wheat flour, and this will add up to a total of 608mg of phosphorus in 100g of fortified white wheat flour (with 108mg of phosphorus initially present in 100g of unfortified white wheat flour).
Making of breads:
Four different types of bread will be made:
White bread unfortified (WB) White bread fortified with lysine (WB-L) White bread fortified with phosphorus (WB-P) White bread fortified with lysine and phosphorus (WB-LP)
Acceptability of the four different breads:
Bread samples will be tested for acceptability. Panelists (n= 60) will be recruited based on their willingness to participate in the study and their consumption of Arabic bread.
Panelists will be asked to fill a questionnaire and to rate the served samples on a 9-point hedonic scale with 1 representing dislike extremely and 9 representing like extremely for overall acceptability, acceptability of appearance, texture and taste. The order of presentation of the samples will be counterbalanced.
Sensory evaluation of the four different breads:
Panelists (n=24) who are regular consumers of white bread will be recruited to assess any sensory differences between experimental samples of the white bread control and the three white breads supplemented with lysine and/or phosphorus. The triangle test will be used in the difference tests.
All subjects will be asked to sign human subjects consent forms and answer demographic information. Demographic information that will be requested will be: 1) age, 2) gender, 3) frequency of bread consumption, 4) type of bread typically consumed, and 5) what factors influence the panelists' bread purchase.
Twenty four panelists will participate in three triangle test, comparing the white bread control vs. each of the three experimental samples in each test. In the session, subjects will be debriefed about a) the products they will consume, b) the procedures for the testing, c) instructions on how to sample the beverages, and d) how to use the score card. All samples will be presented in a random, balanced order.
Mineral and carbohydrate content of bread:
Phosphorus content of the breads will be determined.
Specific Aim 2: Determine the glycemic response following the consumption of the different fortified breads.
In this experiment, healthy subjects (n=12) will be recruited and asked to maintain their regular dietary and physical activity habits during the entire study course, avoid alcohol consumption as well as any unusual strenuous exercise 24 hours prior to the study.
Exclusion criteria: any significant medical diseases; pregnancy or lactation; regular use of medication that affects body weight; a weight loss of 3% or more in the preceding 3 months.
Following a 12 hour (overnight) fast, subjects will be taken to the testing facility [Faculty of Agriculture and Food Sciences/Department of Nutrition or the Central research unit (CRU)/ American University Hospital] where anthropometric measurements (height, weight) will be taken. A catheter will be inserted for blood withdrawal.
Postprandial glycemic response after consumption of the four fortified breads will be determined.
A crossover design will be used in which each subject will undertake 4 visits in a random order over 4 different days, the difference between the visits being the type of bread to be consumed.
In brief, overnight fasted subjects will be given the bread (50 g of carbohydrate) to ingest within 10-15 min and drink 250 ml of water. Blood samples will be taken immediately before the meal and at 15, 30, 45, 60, 90 and 120 minutes after meal ingestion. Blood will be withdrawn by a trained practitioner and will be used for the determination of glucose.
Glucose area under the curve (AUC) will be calculated. In addition, mineral and several metabolites content of the blood will be measured (glucose, total phosphorus, triglycerides, insulin and GLP-1).
Specific Aim 3: Evaluate the variation in Energy Expenditure after the consumption of the fortified breads.
Subject recruitment: 16 healthy subjects in total will be recruited. 14 subjects will be required in order to be able to detect significance at the level of 0.05, using a 25% difference between treatments and 90% power. But, a total number of 16 subjects will be recruited in order to allow for the loss which might take place due to the dropping out.
Inclusion criteria: 16 subjects (BMI between 20 and 25) will be recruited. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| White bread unfortified (WB) | Experimental | Dietary Supplement: lysine and phosphorusbread with no lysine no phosphorus |
| White bread fortified with lysine (WB-L) | Experimental | Dietary Supplement: lysine and phosphorusBread with lysine |
| White bread fortified with phosphorus (WB-P) | Experimental | Dietary Supplement: lysine and phosphorusbread with phosphorus |
| White bread fortified with lysine and phosphorus (WB-LP) | Experimental | Dietary Supplement: lysine and phosphorusBread with phosphorus and lysine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lysine and phosphorusaddition of lysine and essential amino acid and/or phosphorus an essential mineral | Dietary supplement | White bread fortified with lysine (WB-L), White bread fortified with lysine and phosphorus (WB-LP), White bread fortified with phosphorus (WB-P), White bread unfortified (WB) |
Primary outcome
Postprandial glycemia
Time frame: 120 min
postprandial blood glucose level
Energy expenditure
Time frame: 240 min
Postprandial energy expenditure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Obeid, PhD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lysine and phosphorus in people with Postprandial Hyperglycemia and Energy Expenditure, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glycemia (time frame: 120 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.