Postprandial ResponsesNCT04725955
Postprandial Responses to Hydroxytyrosol-enriched Bread
A study testing Enriched wheat bread in people with Postprandial Responses, run by Harokopio University at 1 site in Greece.
Trial summary
The amelioration of postprandial glucose and insulin responses to bread is of great importance since it may have significant beneficial effects on health. A number of studies have shown that hydroxytyrosol may have positive metabolic effects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Responses
- What is being tested?
- Enriched wheat bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 31 Jan 2021to 15 Nov 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal body mass index
- Stable body weight for at least 3 months before enrollment
- Normal exercise, eating and drinking habits
Who cannot join
- Pregnancy and lactation
- Chronic medical illness (diabetes mellitus, cardiovascular disease, chronic liver, kidney, polycystic ovary syndrome or untreated thyroid disease)
- Use of nutritional supplements
- History of drug and/or alcohol abuse
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
Athens, Attica, 11527
About this study
Official title: Postprandial Responses of Healthy Subjects to Wheat Bread Enriched With Encapsulated Hydroxytyrosol
The amelioration of postprandial glucose and insulin responses to bread is of great importance since it may have significant beneficial effects on health. A number of studies have shown that hydroxytyrosol may have positive metabolic effects. However, this compound presents high hydrophilicity which constitutes the major barrier to its potential application in foods. Microencapsulation arises as a technological strategy to protect it and increase its stability. Alpha-cyclodextrin besides being a great carrier molecule, seems to also be beneficial to postprandial glucose levels. Enrichment of bread with encapsulated hydroxytyrosol could examine potential postprandial benefits.
Ten healthy normoglycemic subjects will participate in the study and will be provided with either a solution of glucose (reference food) or white wheat bread or wheat bread enriched with a-cyclodextrin or wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin, with 1-week intervals in amounts that yielded 50 g of available carbohydrates. Venous blood samples will be collected before consumption and at 30, 45, 60, 90, 120 and 180 min postprandially. Postprandial glucose, insulin and appetite-related hormone responses as well as glycemic index (GI) and subjective appetite ratings will be evaluated.
- Conditions
- Postprandial Responses
- Being tested
- Enriched wheat bread
- Keywords
- hydroxytyrosol, a-cyclodextrin, bread, glycaemic index, appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched wheat breadOther
Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).
| Study group | Role | What they receive |
|---|---|---|
| Glucose Solution | Placebo comparator | Not described Receives: Other: Enriched wheat bread |
| Wheat bread enriched with a-cyclodextrin | Active comparator | Not described Receives: Other: Enriched wheat bread |
| Wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin | Experimental | Not described Receives: Other: Enriched wheat bread |
| White wheat bread | Placebo comparator | Not described Receives: Other: Enriched wheat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic Index
Glycaemic Index of the enriched breads
Measured: Change between preprandial glucose measurements until 120 minutes postprandially
Secondary outcomes (2)
Insulin Response
Insulin Responses of the volunteers to the enriched breads (by a sandwich ELISA method, using a commercially available human insulin kit)
Measured: Change between preprandial insulin measurements until 180 minutes postprandially
Appetite ratings
Appetite ratings after the consumption of the enriched breads (evaluation of subjective appetite ratings, use of visual analogue scales)
Measured: Change between preprandial subjective appetite measurements until 180 minutes postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start31 Jan 2021
- Primary completion30 Apr 2021
- Study completion15 Nov 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 Postprandial ResponsesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 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, Vaios T. Karathanos, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725955
- Sponsor's protocol ID
- Harokopio_Hydroxytyrosol
- Status last verified
- Nov 2021
- First submitted
- 19 Jan 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Binou P, Stergiou A, Kosta O, Tentolouris N, Karathanos VT. Positive postprandial glycaemic and appetite-related effects of wheat breads enriched with either alpha-cyclodextrin or hydroxytyrosol/alpha-cyclodextrin inclusion complex. Eur J Nutr. 2022 Oct;61(7):3809-3819. doi: 10.1007/s00394-022-02913-z. Epub 2022 Jun 6.
PubMed 35668121
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Responses of Healthy Subjects to Wheat Bread Enriched With Encapsulated Hydroxytyrosol
- ClinicalTrials.gov ID
- NCT04725955
- Acronym / sponsor ID
- Harokopio_Hydroxytyrosol
- Conditions
- Postprandial Responses
- Keywords
- hydroxytyrosol, a-cyclodextrin, bread, glycaemic index, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 27 Jan 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.
The amelioration of postprandial glucose and insulin responses to bread is of great importance since it may have significant beneficial effects on health. A number of studies have shown that hydroxytyrosol may have positive metabolic effects. However, this compound presents high hydrophilicity which constitutes the major barrier to its potential application in foods. Microencapsulation arises as a technological strategy to protect it and increase its stability. Alpha-cyclodextrin besides being a great carrier molecule, seems to also be beneficial to postprandial glucose levels. Enrichment of bread with encapsulated hydroxytyrosol could examine potential postprandial benefits.
Ten healthy normoglycemic subjects will participate in the study and will be provided with either a solution of glucose (reference food) or white wheat bread or wheat bread enriched with a-cyclodextrin or wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin, with 1-week intervals in amounts that yielded 50 g of available carbohydrates. Venous blood samples will be collected before consumption and at 30, 45, 60, 90, 120 and 180 min postprandially. Postprandial glucose, insulin and appetite-related hormone responses as well as glycemic index (GI) and subjective appetite ratings will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose Solution | Placebo comparator | Other: Enriched wheat bread |
| Wheat bread enriched with a-cyclodextrin | Active comparator | Other: Enriched wheat bread |
| Wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin | Experimental | Other: Enriched wheat bread |
| White wheat bread | Placebo comparator | Other: Enriched wheat bread |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal body mass index
- Stable body weight for at least 3 months before enrollment
- Normal exercise, eating and drinking habits
Key exclusion criteria (5 listed)
- Pregnancy and lactation
- Chronic medical illness (diabetes mellitus, cardiovascular disease, chronic liver, kidney, polycystic ovary syndrome or untreated thyroid disease)
- Use of nutritional supplements
- History of drug and/or alcohol abuse
- Psychiatric disease
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 |
|---|---|---|
| Enriched wheat breadEither 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates). | Other | Glucose Solution, Wheat bread enriched with a-cyclodextrin, Wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin, White wheat bread |
Primary outcome
Glycaemic Index
Time frame: Change between preprandial glucose measurements until 120 minutes postprandially
Glycaemic Index of the enriched breads
2 secondary outcomes
Insulin Response
Time frame: Change between preprandial insulin measurements until 180 minutes postprandially
Appetite ratings
Time frame: Change between preprandial subjective appetite measurements until 180 minutes postprandially
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 26 Nov 2021.
- Derived from this study: PubMed 35668121Binou P, Stergiou A, Kosta O, Tentolouris N, Karathanos VT. Positive postprandial glycaemic and appetite-related effects of wheat breads enriched with either alpha-cyclodextrin or hydroxytyrosol/alpha-cyclodextrin inclusion complex. Eur J Nutr. 2022 Oct;61(7):3809-3819. doi: 10.1007/s00394-022-02913-z. Epub 2022 Jun 6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched wheat bread in people with Postprandial Responses, 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 3 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 26 Nov 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 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. Some participants in this study may receive a placebo. 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?
Glycaemic Index (time frame: Change between preprandial glucose measurements until 120 minutes postprandially). 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 NCT04725955, 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 26 Nov 2021; AzTrials last refreshed its copy on 26 Oct 2026.