- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04749498
Effects of Barley and Oat Breads on Appetite
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aimed to compare the postprandial effects of ß-glucan on glycemia and appetite of breads derived from oats and barley, which are the best natural grain sources. In addition, the positive health effects of ß-glucan were sought to be determined independent of total dietary fiber intake, using not only WB as the control food but also WWB, which has a dietary fiber content equal to that of breads containing ß-glucan. This study was planned as a multicenter, randomized, double-blind, and crossover. Twenty healthy adults (10 men, 10 women) between the ages of 19-35 years, with normal body weight (BMI 18.5-25 kg /m2) were included in the study. Participants were selected from among Erciyes University students and staff in accordance with the inclusion criteria. The eating behaviors of all participants were also evaluated using the Dutch Eating Behavior Questionnaire before starting the study. Since the total score obtained from this questionnaire >3.5 is considered as restrictive eating behavior, these individuals were not included in the study.
Participants were served barley bread (BB), oat bread (OB), and white bread (WB), and whole wheat bread (WWB) with a standard breakfast on four different days at least two days apart. Breads were prepared with similar amounts of energy, protein, fat, carbohydrate, and fiber (except WB). The test meal was served to the participants at 09:00 and they were asked to consume it within 15 minutes. A visual analog scale (VAS) was used to assess appetite before breakfast and at 15, 30, 60, 90, 120, 150, and 180 minutes after breakfast. Furthermore, the separate VAS components such as hunger, fullness, desire to eat, and prospective food consumption were combined to produce an additional measure termed 'composite appetite score'. For the postprandial glucose assessment, blood glucose measurements were made with the finger-tip glucometer at 0, 15, 30, 45, 60, 90, and 120 minutes. Postprandial appetite and glucose responses were quantified as the incremental area under the curve (iAUC) calculated according to the trapezoidal rule.
At the end of three hours, the ad libitum lunch was served to the participants as a buffet-style, and the energy and macronutrient intakes in this meal were determined. All foods (meatballs, tuna, sauce pasta, yogurt, salad, white bread, apple, banana, yogurt drink, fruit juice, and water) were weighed using a calibrated kitchen scale with an accuracy of ±1g before being served. At lunch, the participants were asked to consume the foods they wanted and continue eating until they felt completely full. After the participants completed their consumption, the remaining amounts were reweighed and the difference with the initial amounts was accepted as the amount consumed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kayseri̇
-
Kayseri, Kayseri̇, Turkey, 38039
- Erciyes University Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Normal-weight (BMI 18.5-25 kg/m2)
- 19-35 years
- Having a <3.5 score on the Dutch Eating Behavior Questionnaire (considered as unrestrictive eating behavior)
Exclusion Criteria:
- Applying an energy-restricted diet in the last three months
- Having a change in body weight >5 kg in the last three months
- Vegans
- Having any chronic diseases such as diabetes, hypertension, etc.
- Physician-diagnosed medications or conditions that influence metabolism
- Having fasting glucose >100 mg/dl
- Smoking
- Exercising heavily
- Having chewing/swallowing difficulties or sensitivity/allergies to any food to be used in the study
- Lack of appetite
- Pregnant and lactating women
- Skipping breakfast meals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: White Bread
White bread with a standard test breakfast
|
Test breakfast with white bread was served after 12-hours of fasting and participants were asked to consume the meal in full, within 15 minutes.
|
|
Active Comparator: Whole Wheat Bread
Whole wheat bread with a standard test breakfast
|
In a crossover design, this bread was served with a standard breakfast to compare other breads.
|
|
Experimental: Barley Bread
Barley bread with a standard test breakfast
|
In a crossover design, this bread was served with a standard breakfast to compare other breads.
|
|
Experimental: Oat Bread
Oat bread with a standard test breakfast
|
In a crossover design, this bread was served with a standard breakfast to compare other breads.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial appetite response
Time Frame: Three hours postprandial period (from fasting to 180 minutes after the test breakfast)
|
The separate visual analog scale factors like hunger, fullness, desiring for eat, and prospective food consumption were combined to produce an additional measure termed 'composite appetite score'.
This average appetite score was computed for 0, 15, 30, 60, 90, 120, 150, and 180 minutes using the following equation: [(hunger + desire to eat + prospective food consumption + (100 - fullness)]/4 Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
Postprandial apetite response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using composite appetite scores at time points 0, 15, 30, 60, 90, 120, 150, and 180 minutes.
Higher values represent a worse outcome.
|
Three hours postprandial period (from fasting to 180 minutes after the test breakfast)
|
|
Postprandial glucose response
Time Frame: Two hours postprandial period (from fasting to 120 minutes after the test breakfast)
|
Postprandial glucose response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes.
Higher values represent a worse outcome.
|
Two hours postprandial period (from fasting to 120 minutes after the test breakfast)
|
|
Subsequent energy consumption
Time Frame: Three hours after consuming the test breakfast (at 180 minutes)
|
Energy intake at ad libitum lunch was calculated.
|
Three hours after consuming the test breakfast (at 180 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual appeal of test bread
Time Frame: Immediately after consuming test meal (at 15 minutes)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the visual appeal of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 minutes)
|
|
Smell of test bread
Time Frame: Immediately after consuming test meal (at 15 minutes)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the smell of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 minutes)
|
|
Taste of test bread
Time Frame: Immediately after consuming test meal (at 15 minutes)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the taste of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 minutes)
|
|
Aftertaste of test bread
Time Frame: Immediately after consuming test meal (at 15 minutes)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "Is there any perceived taste in your mouth after test meal?
(Much - None)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a better outcome.
|
Immediately after consuming test meal (at 15 minutes)
|
|
Palatability of test bread
Time Frame: Immediately after consuming test meal (at 15 minutes)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the palatability of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeynep Caferoglu, PhD, Erciyes University Faculty of Health Sciences 38039 Kayseri / Turkey
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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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