Prediabetes Intervention With Tea

Diabetes Mellitus, Type 2 Clinical Trial

— PREVENT  

Official title:

PREVENT - Prediabetes Intervention With Olive Leaf Tea

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05583045
• Other study ID #: 83/2022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: October 2022
• Source: Instituto Politécnico de Bragança
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pre Diabetes
• Prediabetic State

Intervention

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)

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

Locations

Country	Name	City	State
Portugal	Instituto Politécnico de Bragança	Bragança

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Politécnico de Bragança	European Social Fund, Unidade Local de Saúde do Nordeste

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes	12 weeks
Secondary	Fasting Plasma Glicose	Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes	12 weeks
Secondary	Insulin	Effect of olive leaf tea (OLT) on Insulin after 12 weeks of intervention in individuals with prediabetes	12 weeks
Secondary	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
Secondary	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
Secondary	Alkaline Phosphatase	Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes	12 weeks
Secondary	Bilirubin	Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes	12 weeks
Secondary	Creatinine	Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes	12 weeks