HealthyNCT04749498
Effects of Barley and Oat Breads on Appetite
A study testing White Bread, Whole Wheat Bread and Barley Bread in people with Healthy and Appetitive Behavior, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the postprandial effects of ß-glucan derived from oats bread (OB) and barley bread (BB) on appetite and glycemia. A randomized, double-blind, crossover trial included 20 healthy individuals. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Appetitive Behavior
- What is being tested?
- White Bread, Whole Wheat Bread and Barley Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Feb 2021
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Health Sciences
Kayseri, Kayseri̇, 38039
About this study
This study aimed to compare the postprandial effects of ß-glucan derived from oats bread (OB) and barley bread (BB) on appetite and glycemia. A randomized, double-blind, crossover trial included 20 healthy individuals. All participants consumed BB, white bread (WB), and whole wheat bread (WWB) with a standard breakfast and then were served an ad libitum lunch on four different days. 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. Blood glucose levels were measured 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.
Read the 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.
- Conditions
- Healthy, Appetitive Behavior
- Being tested
- White Bread, Whole Wheat Bread, Barley Bread, Oat Bread
- Keywords
- appetite, barley, β-glucan, bread, glucose, oats, food intake
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White BreadOther
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.
Whole Wheat BreadOther
In a crossover design, this bread was served with a standard breakfast to compare other breads.
Barley BreadOther
In a crossover design, this bread was served with a standard breakfast to compare other breads.
Oat BreadOther
In a crossover design, this bread was served with a standard breakfast to compare other breads.
| Study group | Role | What they receive |
|---|---|---|
| White Bread | Active comparator | White bread with a standard test breakfast Receives: Other: White Bread |
| Whole Wheat Bread | Active comparator | Whole wheat bread with a standard test breakfast Receives: Other: Whole Wheat Bread |
| Barley Bread | Experimental | Barley bread with a standard test breakfast Receives: Other: Barley Bread |
| Oat Bread | Experimental | Oat bread with a standard test breakfast Receives: Other: Oat Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial appetite response
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.
Measured: Three hours postprandial period (from fasting to 180 minutes after the test breakfast)
Postprandial glucose response
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.
Measured: Two hours postprandial period (from fasting to 120 minutes after the test breakfast)
Subsequent energy consumption
Energy intake at ad libitum lunch was calculated.
Measured: Three hours after consuming the test breakfast (at 180 minutes)
Secondary outcomes (5)
Visual appeal of test bread
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.
Measured: Immediately after consuming test meal (at 15 minutes)
Smell of test bread
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.
Measured: Immediately after consuming test meal (at 15 minutes)
Taste of test bread
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.
Measured: Immediately after consuming test meal (at 15 minutes)
Aftertaste of test bread
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.
Measured: Immediately after consuming test meal (at 15 minutes)
Palatability of test bread
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.
Measured: Immediately after consuming test meal (at 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Apr 2019
- Primary completion1 Mar 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Caferoglu, PhD, TC Erciyes University
- Investigators
- Zeynep Caferoglu, PhD, Principal investigator, Erciyes University Faculty of Health Sciences 38039 Kayseri / Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749498
- Sponsor's protocol ID
- TSA-2019-8761
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caferoglu Z, Aytekin Sahin G, Gonulalan Z, Hatipoglu N. Effects of whole-grain barley and oat beta-glucans on postprandial glycemia and appetite: a randomized controlled crossover trial. Food Funct. 2022 Oct 3;13(19):10225-10234. doi: 10.1039/d2fo01717b.
PubMed 36124913
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Barley and Oat Breads on Appetite
- ClinicalTrials.gov ID
- NCT04749498
- Acronym / sponsor ID
- TSA-2019-8761
- Conditions
- Healthy, Appetitive Behavior
- Keywords
- appetite, barley, β-glucan, bread, glucose, oats, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 11 Feb 2021 (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.
This study aimed to compare the postprandial effects of ß-glucan derived from oats bread (OB) and barley bread (BB) on appetite and glycemia. A randomized, double-blind, crossover trial included 20 healthy individuals. All participants consumed BB, white bread (WB), and whole wheat bread (WWB) with a standard breakfast and then were served an ad libitum lunch on four different days. 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. Blood glucose levels were measured 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| White Bread | Active comparator | Other: White BreadWhite bread with a standard test breakfast |
| Whole Wheat Bread | Active comparator | Other: Whole Wheat BreadWhole wheat bread with a standard test breakfast |
| Barley Bread | Experimental | Other: Barley BreadBarley bread with a standard test breakfast |
| Oat Bread | Experimental | Other: Oat BreadOat bread with a standard test breakfast |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| White BreadTest breakfast with white bread was served after 12-hours of fasting and participants were asked to consume the meal in full, within 15 minutes. | Other | White Bread |
| Whole Wheat BreadIn a crossover design, this bread was served with a standard breakfast to compare other breads. | Other | Whole Wheat Bread |
| Barley BreadIn a crossover design, this bread was served with a standard breakfast to compare other breads. | Other | Barley Bread |
| Oat BreadIn a crossover design, this bread was served with a standard breakfast to compare other breads. | Other | Oat Bread |
Primary outcome
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.
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.
Subsequent energy consumption
Time frame: Three hours after consuming the test breakfast (at 180 minutes)
Energy intake at ad libitum lunch was calculated.
5 secondary outcomes
Visual appeal of test bread
Time frame: Immediately after consuming test meal (at 15 minutes)
Smell of test bread
Time frame: Immediately after consuming test meal (at 15 minutes)
Taste of test bread
Time frame: 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 bread
Time frame: Immediately after consuming test meal (at 15 minutes)
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 15 Feb 2021.
- Derived from this study: PubMed 36124913Caferoglu Z, Aytekin Sahin G, Gonulalan Z, Hatipoglu N. Effects of whole-grain barley and oat beta-glucans on postprandial glycemia and appetite: a randomized controlled crossover trial. Food Funct. 2022 Oct 3;13(19):10225-10234. doi: 10.1039/d2fo01717b.
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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.
Zeynep Caferoglu, PhD principal investigator
Erciyes University Faculty of Health Sciences 38039 Kayseri / Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Bread, Whole Wheat Bread and Barley Bread in people with Healthy and Appetitive Behavior, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 12 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 15 Feb 2021. 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 Turkey (Türkiye). 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 appetite response (time frame: Three hours postprandial period (from fasting to 180 minutes after the test breakfast)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04749498, which also lists 1 linked publication.
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 15 Feb 2021.