Diabetes Mellitus, Type 2, Pre Diabetes
Conditions
Keywords
Olive leaves, Diabetes, Glycaemic control, Insulin resistance
Brief 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 insulin resistance in individuals with pre-diabetes.
Detailed description
This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment
Interventions
OTHEROlive Leaf Tea
Olive leaf tea (individual tea bags provided to participants with instructions of preparation)
BEHAVIORALLifestyle 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)
OTHERPlacebo tea
Placebo tea containing 2,6g cellulose and a caramel coloring
Sponsors
Unidade Local de Saúde do Nordeste
European Social Fund
Instituto Politécnico de Bragança
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | 12 weeks | Effect of olive leaf tea (OLT) on Insulin after 12 weeks of intervention in individuals with prediabetes |
| Cholesterol Total, c-HDL, c-LDL and triglycerides | 12 weeks | Effect of olive leaf tea (OLT) on CT, c-HDL, c-LDL and TG after 12 weeks of intervention in individuals with prediabetes |
| Aspartate transaminase (AST) and Alanine transaminase (ALT) | 12 weeks | Effect of olive leaf tea (OLT) on AST and ALT after 12 weeks of intervention in individuals with prediabetes |
| Fasting Plasma Glicose | 12 weeks | Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes |
| Bilirubin | 12 weeks | Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes |
| Creatinine | 12 weeks | Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes |
| Alkaline Phosphatase | 12 weeks | Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes |
Countries
Portugal
Outcome results
None listed