Prediabetes Intervention With Tea

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment

Official Title
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PREVENT - Prediabetes Intervention With Olive Leaf Tea

Conditions
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Diabetes Mellitus, Type 2, Pre Diabetes

Intervention / Treatment
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* Other: Olive Leaf Tea
* Behavioral: Lifestyle behavior change program (LBC)
* Other: Placebo tea


Participation Criteria
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Eligibility Criteria
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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: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive Leaf Tea (OLT)<br>Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program. | Other: Olive Leaf Tea<br>* Olive leaf tea (individual tea bags provided to participants with instructions of preparation)<br>Behavioral: Lifestyle behavior change program (LBC)<br>* 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)<br>|
| Placebo Comparator: Placebo tea (CON)<br>Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program | Behavioral: Lifestyle behavior change program (LBC)<br>* 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)<br>Other: Placebo tea<br>* Placebo tea containing 2,6g cellulose and a caramel coloring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olive leaves, Diabetes, Glycaemic control, Insulin resistance