Prediabetes Intervention With Tea

Instituto Politécnico de Bragança140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

140

Conditions

Diabetes Mellitus, Type 2 Pre Diabetes

Interventions

Olive Leaf TeaOTHER

Olive leaf tea (individual tea bags provided to participants with instructions of preparation)

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 teaOTHER

Placebo tea containing 2,6g cellulose and a caramel coloring

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Politécnico de Bragança

Bragança, Portugal

Outcomes

Primary Outcomes

HbA1c

Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes

Time frame: 12 weeks

Secondary Outcomes

Fasting Plasma Glicose

Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes

Time frame: 12 weeks

Insulin

Effect of olive leaf tea (OLT) on Insulin after 12 weeks of intervention in individuals with prediabetes

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Alkaline Phosphatase

Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes

Time frame: 12 weeks

Bilirubin

Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes

Time frame: 12 weeks

Creatinine

Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes

Data from ClinicalTrials.gov

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