DiabetesNCT02669693
Effect of Olives on Glycaemic Response in Vivo
A study testing bread without olives and bread with olives in people with Diabetes, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This research is aimed at determining whether the presence of oleuropein in olives (Olea europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will be required to consume commercially available olives together with white bread, and their glycaemic response will be measured. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- bread without olives and bread with olives
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to Jul 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75
- Fasting glucose (blood glucose level before breakfast) 3.9 -5.9mmol/L
Who cannot join
- Diabetic
- on long term prescribed medication (except contraceptives)
- pregnant or lactating
- on special diet (for losing weight or fruit extracts supplements)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Food Science and Nutrition, University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
This research is aimed at determining whether the presence of oleuropein in olives (Olea europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will be required to consume commercially available olives together with white bread, and their glycaemic response will be measured. The blood glucose response of bread will be determined initially as a control/reference. Food samples and control will be consumed in random order.
The recent rise in the cases of Diabetes mellitus in both children and adults has raised a concern for the need to proffer immediate solutions amongst scientists in the fields of medicine food science and nutrition. One of the approaches of reducing postprandial hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This is potentially achieved through the inhibition of the activities of starch digesting enzymes namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such as acarbose and miglitol which have been quite efficient in these inhibitory functions but not without associated side effects and complications such as liver toxicity, etc, arising from to long term usage of such drugs. It therefore becomes imperative for natural substitutes from food sources to be explored as better alternatives. At the moment several plant foods are under investigation as suitable alternatives, and olives appear to be quite promising in this regard. There are quite a few studies that have reported the inhibitory activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing is very scarce.
It is expected that the research outcome will be a gateway to the reduction and control of the incidence of diabetes mellitus.
Read the detailed description
Prior to commencement of the study, potential volunteers will be given a clear, concise Participant Information Sheet and Informed Consent Form by the investigator to read, complete and sign in their own time. The investigator will answer all questions to the satisfaction of the individual and will not influence the decision of taking part in the study. The participants will be free to withdraw from the study at any point without providing a reason. The written consent form will be signed and dated at least 2 days prior to enrolment in the study by the volunteers and the Investigator. It will be photocopied and one copy will be kept by the Investigator (for the study records) and one by the volunteer. Participation by the volunteers is conditional upon receiving the written consent by the volunteer.
Candidates will be asked to complete a questionnaire in order to assess their suitability for the study. The information pertains to their lifestyle and may be considered a sensitive issue, however each volunteer will be assured of confidentiality and that participation is entirely voluntary. The information on the questionnaire will include height, weight, gender, age and relevant medical history. Confidentiality of all participants' information will be maintained. Identification will be coded using random ID numbers that will be assigned on the day of study. All data collected will be treated as confidential and stored securely in a locked filing cabinet according to current University regulations. The linkage between individual identity and ID number will be kept in written form only and stored in a locked filling cabinet in a restricted access area, thus it will not be possible to identify individual participants from the ID numbers. Data evaluation will only be performed using ID numbers. In accordance with the University guidelines on the password protected M-drive of the University server, anonymised data will be stored for at least 5 years.
Blood glucose will be measured after consumption of test meal/control using a commercially available glucometer which is available to be bought by any member of the public and people already use them on their own. It measures glucose concentrations immediately and meets the accuracy requirement for the ISO 15197 standard. A drop of blood is enough and is obtained from participants by means of a mild finger prick using a sterile puncture device designed for this purpose for each time point. The finger prick protocol is the WHO/FAO 1998 glycaemic index approved protocol. Nine (9) finger pricks will be needed (0, 15, 30, 45, 60, 90, 120, 150 and 180minutes) will be needed per study session.
- Conditions
- Diabetes
- Being tested
- bread without olives, bread with olives
- Keywords
- Olives, oleuropein
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bread without olivesDietary supplement
bread with olivesDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| bread without olives | Placebo comparator | Intervention (no olives): Subjects will consume a meal of 109 g white bread and 200 of ml water, and post-prandial blood glucose measured over a 3 hour period. Receives: Dietary Supplement: bread without olives |
| bread with olives | Active comparator | Intervention (olives 100 g): Subjects will consume a meal of 109 g white bread, 100 g of olives and 200 of ml water, and post-prandial blood glucose measured over a 3 hour period. Receives: Dietary Supplement: bread with olives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial blood glucose concentration
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Williamson, University of Leeds
- Investigators
- Gary Williamson, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669693
- Sponsor's protocol ID
- MEEC 12-037a
- Status last verified
- Mar 2017
- First submitted
- 19 Jan 2016
- Last updated
- 23 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olives on Glycaemic Response in Vivo
- ClinicalTrials.gov ID
- NCT02669693
- Acronym / sponsor ID
- MEEC 12-037a
- Conditions
- Diabetes
- Keywords
- Olives, oleuropein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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 research is aimed at determining whether the presence of oleuropein in olives (Olea europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will be required to consume commercially available olives together with white bread, and their glycaemic response will be measured. The blood glucose response of bread will be determined initially as a control/reference. Food samples and control will be consumed in random order.
The recent rise in the cases of Diabetes mellitus in both children and adults has raised a concern for the need to proffer immediate solutions amongst scientists in the fields of medicine food science and nutrition. One of the approaches of reducing postprandial hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This is potentially achieved through the inhibition of the activities of starch digesting enzymes namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such as acarbose and miglitol which have been quite efficient in these inhibitory functions but not without associated side effects and complications such as liver toxicity, etc, arising from to long term usage of such drugs. It therefore becomes imperative for natural substitutes from food sources to be explored as better alternatives. At the moment several plant foods are under investigation as suitable alternatives, and olives appear to be quite promising in this regard. There are quite a few studies that have reported the inhibitory activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing is very scarce.
It is expected that the research outcome will be a gateway to the reduction and control of the incidence of diabetes mellitus.
Detailed description
Prior to commencement of the study, potential volunteers will be given a clear, concise Participant Information Sheet and Informed Consent Form by the investigator to read, complete and sign in their own time. The investigator will answer all questions to the satisfaction of the individual and will not influence the decision of taking part in the study. The participants will be free to withdraw from the study at any point without providing a reason. The written consent form will be signed and dated at least 2 days prior to enrolment in the study by the volunteers and the Investigator. It will be photocopied and one copy will be kept by the Investigator (for the study records) and one by the volunteer. Participation by the volunteers is conditional upon receiving the written consent by the volunteer.
Candidates will be asked to complete a questionnaire in order to assess their suitability for the study. The information pertains to their lifestyle and may be considered a sensitive issue, however each volunteer will be assured of confidentiality and that participation is entirely voluntary. The information on the questionnaire will include height, weight, gender, age and relevant medical history. Confidentiality of all participants' information will be maintained. Identification will be coded using random ID numbers that will be assigned on the day of study. All data collected will be treated as confidential and stored securely in a locked filing cabinet according to current University regulations. The linkage between individual identity and ID number will be kept in written form only and stored in a locked filling cabinet in a restricted access area, thus it will not be possible to identify individual participants from the ID numbers. Data evaluation will only be performed using ID numbers. In accordance with the University guidelines on the password protected M-drive of the University server, anonymised data will be stored for at least 5 years.
Blood glucose will be measured after consumption of test meal/control using a commercially available glucometer which is available to be bought by any member of the public and people already use them on their own. It measures glucose concentrations immediately and meets the accuracy requirement for the ISO 15197 standard. A drop of blood is enough and is obtained from participants by means of a mild finger prick using a sterile puncture device designed for this purpose for each time point. The finger prick protocol is the WHO/FAO 1998 glycaemic index approved protocol. Nine (9) finger pricks will be needed (0, 15, 30, 45, 60, 90, 120, 150 and 180minutes) will be needed per study session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bread without olives | Placebo comparator | Dietary Supplement: bread without olivesIntervention (no olives): Subjects will consume a meal of 109 g white bread and 200 of ml water, and post-prandial blood glucose measured over a 3 hour period. |
| bread with olives | Active comparator | Dietary Supplement: bread with olivesIntervention (olives 100 g): Subjects will consume a meal of 109 g white bread, 100 g of olives and 200 of ml water, and post-prandial blood glucose measured over a 3 hour period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-75
- Fasting glucose (blood glucose level before breakfast) 3.9 -5.9mmol/L
Key exclusion criteria (4 listed)
- Diabetic
- on long term prescribed medication (except contraceptives)
- pregnant or lactating
- on special diet (for losing weight or fruit extracts supplements)
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 |
|---|---|---|
| bread without olives | Dietary supplement | bread without olives |
| bread with olives | Dietary supplement | bread with olives |
Primary outcome
Post-prandial blood glucose concentration
Time frame: 180 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 23 Mar 2017.
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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.
Gary Williamson, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bread without olives and bread with olives in people with Diabetes, run by University of Leeds at 1 site in United Kingdom.
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 4 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 23 Mar 2017. 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 United Kingdom. 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?
Post-prandial blood glucose concentration (time frame: 180 minutes). 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 23 Mar 2017.