Diabetes Mellitus, Type 2PREVENTNCT05583045
Prediabetes Intervention With Tea
A study testing Olive Leaf Tea and Lifestyle behavior change program (LBC) in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by Instituto Politécnico de Bragança at 1 site in Portugal.
Trial summary
The goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre Diabetes
- What is being tested?
- Olive Leaf Tea and Lifestyle behavior change program (LBC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2022to Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:
- Fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mml per liter);
- Plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mml per liter);
- Glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mml per mole).
Who cannot join
- Current use of medication for lowering blood cholesterol, glucose or hypertension;
- History of chronic or severe diseases that may affect study outcomes or limit study participation;
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVENT - Prediabetes Intervention With Olive Leaf Tea
The goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate insulin resistance in individuals with pre-diabetes.
Read the detailed description
This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Being tested
- Olive Leaf Tea, Lifestyle behavior change program (LBC), Placebo tea
- Keywords
- Olive leaves, Diabetes, Glycaemic control, Insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Leaf TeaOther
Olive leaf tea (individual tea bags provided to participants with instructions of preparation)
Lifestyle behavior change program (LBC)Behavioural
Lifestyle behavior change program as defined by America Diabetes Association on "Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Providers"(Association 2022)
Placebo teaOther
Placebo tea containing 2,6g cellulose and a caramel coloring
| Study group | Role | What they receive |
|---|---|---|
| Olive Leaf Tea (OLT) | Experimental | Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program. Receives: Other: Olive Leaf Tea; Behavioral: Lifestyle behavior change program (LBC) |
| Placebo tea (CON) | Placebo comparator | Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program Receives: Behavioral: Lifestyle behavior change program (LBC); Other: Placebo tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Secondary outcomes (7)
Fasting Plasma Glicose
Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Insulin
Effect of olive leaf tea (OLT) on Insulin after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Cholesterol Total, c-HDL, c-LDL and triglycerides
Effect of olive leaf tea (OLT) on CT, c-HDL, c-LDL and TG after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Aspartate transaminase (AST) and Alanine transaminase (ALT)
Effect of olive leaf tea (OLT) on AST and ALT after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Alkaline Phosphatase
Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Bilirubin
Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Creatinine
Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Model description
- Participants will be divided into two groups (A or B): A: Olive leaf tea + Lifestyle behavior change program B: Placebo tea + Lifestyle behavior change program
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Bragança
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saude do Nordeste, European Social Fund
- Responsible party
- Principal investigator, Manuela Meireles, Instituto Politécnico de Bragança
- Investigators
- Manuela Meireles, PhD, Principal investigator, Instituto Politécnico de Bragança
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583045
- Sponsor's protocol ID
- 83/2022
- Acronym
- PREVENT
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant data will be collected anonymously and only individual data related to the outcomes will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENT - Prediabetes Intervention With Olive Leaf Tea
- ClinicalTrials.gov ID
- NCT05583045
- Acronym / sponsor ID
- PREVENT / 83/2022
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Keywords
- Olive leaves, Diabetes, Glycaemic control, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto Politécnico de BragançaUniversity, hospital or other
- Collaborators
- Unidade Local de Saude do Nordeste, European Social Fund
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 17 Oct 2022 (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 goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate insulin resistance in individuals with pre-diabetes.
Detailed description
This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups (A or B): A: Olive leaf tea + Lifestyle behavior change program B: Placebo tea + Lifestyle behavior change program
| Arm | Type | Receives |
|---|---|---|
| Olive Leaf Tea (OLT) | Experimental | Other: Olive Leaf Tea, Behavioral: Lifestyle behavior change program (LBC)Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program. |
| Placebo tea (CON) | Placebo comparator | Behavioral: Lifestyle behavior change program (LBC), Other: Placebo teaDaily intake, for 12 weeks, of placebo tea + lifestyle behavior change program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:
- Fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mml per liter);
- Plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mml per liter);
- Glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mml per mole).
Key exclusion criteria (3 listed)
- Current use of medication for lowering blood cholesterol, glucose or hypertension;
- History of chronic or severe diseases that may affect study outcomes or limit study participation;
- Pregnancy and breastfeeding
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 |
|---|---|---|
| Olive Leaf TeaOlive leaf tea (individual tea bags provided to participants with instructions of preparation) | Other | Olive Leaf Tea (OLT) |
| Lifestyle behavior change program (LBC)Lifestyle behavior change program as defined by America Diabetes Association on "Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Providers"(Association 2022) | Behavioural | Olive Leaf Tea (OLT), Placebo tea (CON) |
| Placebo teaPlacebo tea containing 2,6g cellulose and a caramel coloring | Other | Placebo tea (CON) |
Primary outcome
HbA1c
Time frame: 12 weeks
Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes
7 secondary outcomes
Fasting Plasma Glicose
Time frame: 12 weeks
Insulin
Time frame: 12 weeks
Cholesterol Total, c-HDL, c-LDL and triglycerides
Time frame: 12 weeks
Aspartate transaminase (AST) and Alanine transaminase (ALT)
Time frame: 12 weeks
Alkaline Phosphatase
Time frame: 12 weeks
Bilirubin
Time frame: 12 weeks
Creatinine
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: Yes. All participant data will be collected anonymously and only individual data related to the outcomes will be available upon request
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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.
Manuela Meireles, PhD principal investigator
Instituto Politécnico de Bragança
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Leaf Tea and Lifestyle behavior change program (LBC) in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by Instituto Politécnico de Bragança at 1 site in Portugal.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. 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 Portugal. 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?
Results are not available in the source record.
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?
HbA1c (time frame: 12 weeks). 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 19 Oct 2022; AzTrials last refreshed its copy on 29 Oct 2026.