- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598986
Effect of Macronutrient Supplementation on Glycemic Index of Pita Bread
Glycemic Index of Bread: Fiber or Minerals? This is the Question.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The production of white flour requires the milling of the wheat grain and extraction of a proportion of the grains. The level of 80% extraction is the most-commonly used in the production of white flour in the market and this process leads to a substantial loss of vitamins and minerals (Table 1). These vitamins and minerals are known to affect energy metabolism. For example, thiamin is known to affect carbohydrate metabolism and low thiamin intake is known to cause Beriberi. This has led to the establishment of an acceptable carbohydrate and energy: thiamin ratio (0.4mg of thiamin/1000 kcal) and many countries are fortifying their white wheat flour with thiamin to sustain an acceptable ratio. Although several minerals are known to affect energy and carbohydrate metabolism no clear ratio has been put in place yet.
Table 1: the effect of milling on mineral content of wheat flour Mineral content Wheat flour (white) Wheat flour (whole grain) Loss (%) Phosphorus (mg/100g) 108 346 69 Potassium (mg/100g) 107 408 74 Magnesium (mg/100g) 22 138 84
Specific Aim 1: Determine the acceptability of mineral fortified white bread. White flour will be supplemented with minerals to produce mineral-fortified bread. The acceptability of the bread will be tested.
White wheat flour (80% extraction) will be fortified with minerals. Potassium phosphate will be used as the source of phosphorus and potassium to fortify white flour. 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). At the same time, magnesium chloride will be used as the source of magnesium. Magnesium chloride is known to be highly soluble and is commonly used as a supplement or fortificant.
Locally produced white wheat flour (80% extraction) and whole grain wheat flour will be purchased and stored at the department. White and whole flour samples (n=3) will be analyzed for their content of phosphorus, magnesium and potassium according to standard procedures
Fortification:
White Bread Restoration (WB-R): A quantity of white flour will be fortified with minerals to a level that restores its content of minerals to that of whole grain wheat flour.
Based on data from the above table, white flour restoration requires the addition of:
250 mg of P/100g white flour (total P =358mg/100g) and 100 mg of Mg/100g white flour (total Mg =122mg/100g)
White Bread Fortification (WB-F): A quantity of white flour will be fortified with minerals to a level that is 100% higher than that of whole grain wheat flour.
Based on data from the above table, white flour fortification requires the addition of:
580mg of P/100g white flour (total P= 688mg/100g) 250mg of Mg/100g white flour (total Mg= 272 mg/100g)
Making of bread:
Four different types of bread will be made:
White bread (WB) White bread with mineral restoration (WB-R) White bread with mineral fortification (WB-F) Whole grain bread (WGB)
Acceptability of bread:
Bread samples (white bread and whole wheat bread controls and the 2 experimental 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.
Mineral and carbohydrate content of bread:
Phosphorus, potassium and magnesium and starch contents of the bread will be determined.
Specific Aim 2: Assess any sensory differences between the different bread treatments. The bread making step will be the same as the above. Panelists who are regular consumers of white bread will be recruited to assess any sensory differences between the white bread control and the white bread mineral supplemented experimental samples. 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 .
Specific Aim 3: Determine the glycemic index of the mineral supplemented bread. Glycemic index of the above four different types of bread will be determined.
In this experiment, healthy subjects (n=12) will be 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 include: 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, they 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.
Glycemic index of food will be determined. In brief, overnight fasted subjects will be given the bread (50 g of carbohydrate) to ingest within 10-15 min and drink 250ml 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. The GI value of each food will be calculated as the mean value of : 100 x (AUC test food)/(AUC reference food) in the same subject.
In addition, mineral content of the blood will be determined and several metabolites (glucose, Tg, FFA, P), K, Mg and hormones (insulin) will be measured.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- any disease, pregnant and lactating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: white pita bread
Pita bread made of white wheat flour
|
adding of phosphorus, potassium and magnesium
|
No Intervention: Whole grain pita bread
no macronutrient supplementation
|
|
Experimental: Restored white pita bread
macronutrient supplementation
|
adding of phosphorus, potassium and magnesium
|
Experimental: Fortified white pita bread
macronutrient supplementation 2
|
adding of phosphorus, potassium and magnesium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC of serum glucose
Time Frame: two hours
|
two hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NUT.OO.19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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