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| Name | Class |
|---|---|
| Unidade Local de Saude do Nordeste | OTHER |
| European Social Fund | OTHER |
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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.
This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olive Leaf Tea (OLT) | Experimental | Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program. |
|
| Placebo tea (CON) | Placebo Comparator | Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olive Leaf Tea | Other | Olive leaf tea (individual tea bags provided to participants with instructions of preparation) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glicose | Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes | 12 weeks |
| Insulin | Effect of olive leaf tea (OLT) on Insulin after 12 weeks of intervention in individuals with prediabetes |
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Inclusion Criteria:
At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuela Meireles, PhD | Instituto Politécnico de Bragança | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Politécnico de Bragança | Bragança | 5300-146 | Portugal |
All participant data will be collected anonymously and only individual data related to the outcomes will be available upon request
After the publication of the final results during two years
Will be available upon request to researcher
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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
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The masking is from the responsibility of the tea supplier which was asked to send the tea/placebo codified and only reveal the codification after the end of the trial.
| Lifestyle behavior change program (LBC) | Behavioral | 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 tea | Other | Placebo tea containing 2,6g cellulose and a caramel coloring |
|
| 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 | 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 | 12 weeks |
| Alkaline Phosphatase | Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes | 12 weeks |
| Bilirubin | Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes | 12 weeks |
| Creatinine | Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes | 12 weeks |
| D006943 | Hyperglycemia |
| D006946 | Hyperinsulinism |