Postprandial HyperglycemiaNCT05691686
Bread Structure and Postprandial Metabolic Responses
A study testing Finely milled whole wheat-legume bread, Less processed whole wheat-legume bread and Less processed whole wheat bread in people with Postprandial Hyperglycemia, run by Harokopio University at 1 site in Greece.
Trial summary
The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Finely milled whole wheat-legume bread, Less processed whole wheat-legume bread and Less processed whole wheat bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGreece
- Study dates
- 16 Jan 2023to 31 Oct 2023
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal exercise and dietary habbits
- weight stable for at least 3 months before enrollment
Who cannot join
- pregnancy and lactation
- diabetes
- chronic medical illness
- regular intense exercise (>5 hrs/week)
- alcohol consumption >2 drinks/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.
The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.
Read the detailed description
Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Finely milled whole wheat-legume bread, Less processed whole wheat-legume bread, Less processed whole wheat bread, White wheat bread
- Keywords
- bread, food structure, glycemic control, appetite regulation
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finely milled whole wheat-legume breadOther
The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.
Less processed whole wheat-legume breadOther
The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.
Less processed whole wheat breadOther
The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.
White wheat breadOther
The intervention examines the reference food product in subjects with normal body weight.
| Study group | Role | What they receive |
|---|---|---|
| Finely milled whole wheat-legume bread | Experimental | Treatment with finely milled whole wheat-legume bread. Receives: Other: Finely milled whole wheat-legume bread |
| Less processed whole wheat-legume bread | Experimental | Treatment with less processed whole wheat-legume bread. Receives: Other: Less processed whole wheat-legume bread |
| Less processed whole wheat bread | Experimental | Treatment with of less processed whole wheat bread. Receives: Other: Less processed whole wheat bread |
| Reference Food (white wheat bread) | Active comparator | Treatment with reference food. Receives: Other: White wheat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food.
Blood glucose concentration will be measured for each participant before and after the test foods, with blood samples being collected at specific time points: 0 (before food consumption), 30, 45, 60, 90, 120, 180 minutes postprandially for each food.
Measured: Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).
Secondary outcomes (1)
Subjective appetite ratings
Subjective evaluation of hunger, satiety, and desire to eat with Visual Analogue Scales, before the consumption and 30, 60, 90, 120, 180 minutes after (0-100 mm with 0 indicating no hunger or perceived ability to consume food/no satiety or no fullness). Difference in perception of these parameters will be measured and compared between the experimental condition and the control condition.
Measured: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start16 Jan 2023
- Primary completion15 May 2023
- Study completion31 Oct 2023
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Amalia Yanni, Harokopio University
- Investigators
- Nikolaos Tentolouris, Professor, Study chair, National and Kapodistrian University of AthensVaios Karathanos, Professor, Study chair, Harokopio University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691686
- Sponsor's protocol ID
- 513.26-07-2021
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.
- ClinicalTrials.gov ID
- NCT05691686
- Acronym / sponsor ID
- 513.26-07-2021
- Conditions
- Postprandial Hyperglycemia
- Keywords
- bread, food structure, glycemic control, appetite regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 20 Jan 2023 (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.
The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.
Detailed description
Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Finely milled whole wheat-legume bread | Experimental | Other: Finely milled whole wheat-legume breadTreatment with finely milled whole wheat-legume bread. |
| Less processed whole wheat-legume bread | Experimental | Other: Less processed whole wheat-legume breadTreatment with less processed whole wheat-legume bread. |
| Less processed whole wheat bread | Experimental | Other: Less processed whole wheat breadTreatment with of less processed whole wheat bread. |
| Reference Food (white wheat bread) | Active comparator | Other: White wheat breadTreatment with reference food. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal exercise and dietary habbits
- weight stable for at least 3 months before enrollment
Key exclusion criteria (5 listed)
- pregnancy and lactation
- diabetes
- chronic medical illness
- regular intense exercise (>5 hrs/week)
- alcohol consumption >2 drinks/day
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 |
|---|---|---|
| Finely milled whole wheat-legume breadThe intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight. | Other | Finely milled whole wheat-legume bread |
| Less processed whole wheat-legume breadThe intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight. | Other | Less processed whole wheat-legume bread |
| Less processed whole wheat breadThe intervention examines the effect of less processed whole wheat bread in subjects with normal body weight. | Other | Less processed whole wheat bread |
| White wheat breadThe intervention examines the reference food product in subjects with normal body weight. | Other | Reference Food (white wheat bread) |
Primary outcome
Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food.
Time frame: Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).
Blood glucose concentration will be measured for each participant before and after the test foods, with blood samples being collected at specific time points: 0 (before food consumption), 30, 45, 60, 90, 120, 180 minutes postprandially for each food.
1 secondary outcome
Subjective appetite ratings
Time frame: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total).
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 5 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Nikolaos Tentolouris, Professor study chair
National and Kapodistrian University of Athens
Vaios Karathanos, Professor study chair
Harokopio University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finely milled whole wheat-legume bread, Less processed whole wheat-legume bread and Less processed whole wheat bread in people with Postprandial Hyperglycemia, run by Harokopio University at 1 site in Greece.
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 2 inclusion and 5 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 5 Mar 2024. 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 Greece. 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?
Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food. (time frame: Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).). 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 5 Mar 2024.