Prediabetes Intervention With Tea (PREVENT)

PREVENT - Prediabetes Intervention With Olive Leaf Tea

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2; Pre Diabetes
• Intervention / Treatment: Other: Olive Leaf Tea; Behavioral: Lifestyle behavior change program (LBC); Other: Placebo tea

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Bragança, Portugal, 5300-146
    • Instituto Politécnico de Bragança

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Politécnico de Bragança
• Collaborators: European Social Fund; Unidade Local de Saúde do Nordeste
• Investigators: Principal Investigator: Manuela Meireles, PhD, Instituto Politécnico de Bragança

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Insulin resistance; Glycaemic control; Olive leaves
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: 83/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participant data will be collected anonymously and only individual data related to the outcomes will be available upon request
• IPD Sharing Time Frame: After the publication of the final results during two years
• IPD Sharing Access Criteria: Will be available upon request to researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No