Prediabetes Intervention With Tea

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Pre Diabetes
• Interventions: Other: Olive Leaf Tea; Behavioral: Lifestyle behavior change program (LBC); Other: Placebo tea

• Registration Number: NCT05583045
• Lead Sponsor: Instituto Politécnico de Bragança

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

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19
• Study Start: 2022-11-01
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olive Leaf Tea (OLT)	Olive Leaf Tea	Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program.
Placebo tea (CON)	Lifestyle behavior change program (LBC)	Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program
Placebo tea (CON)	Placebo tea	Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program
Olive Leaf Tea (OLT)	Lifestyle behavior change program (LBC)	Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bilirubin	12 weeks	Effect of olive leaf tea (OLT) on Bilirubin 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
Alkaline Phosphatase	12 weeks	Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes
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
Creatinine	12 weeks	Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes

Trial Locations

Locations (1)

Instituto Politécnico de Bragança; 🇵🇹 Bragança, Portugal