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

Primary Purpose

Postprandial Hyperglycemia, Energy Expenditure

Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
lysine and phosphorus
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Hyperglycemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • American University of BeirutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

bread with no lysine no phosphorus

Bread with lysine

bread with phosphorus

Bread with phosphorus and lysine

Outcomes

Primary Outcome Measures

Postprandial glycemia
postprandial blood glucose level
Energy expenditure
Postprandial energy expenditure

Secondary Outcome Measures

Full Information

First Posted
February 7, 2019
Last Updated
February 11, 2019
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03836495
Brief Title
The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis
Official Title
The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Anticipated)
Study Completion Date
August 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia, Energy Expenditure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
White bread unfortified (WB)
Arm Type
Experimental
Arm Description
bread with no lysine no phosphorus
Arm Title
White bread fortified with lysine (WB-L)
Arm Type
Experimental
Arm Description
Bread with lysine
Arm Title
White bread fortified with phosphorus (WB-P)
Arm Type
Experimental
Arm Description
bread with phosphorus
Arm Title
White bread fortified with lysine and phosphorus (WB-LP)
Arm Type
Experimental
Arm Description
Bread with phosphorus and lysine
Intervention Type
Dietary Supplement
Intervention Name(s)
lysine and phosphorus
Intervention Description
addition of lysine and essential amino acid and/or phosphorus an essential mineral
Primary Outcome Measure Information:
Title
Postprandial glycemia
Description
postprandial blood glucose level
Time Frame
120 min
Title
Energy expenditure
Description
Postprandial energy expenditure
Time Frame
240 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
omar obeid, PhD
Phone
+961350000
Ext
4440
Email
oo01@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Obeid, PhD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Obeid, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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