PREVENT: Prediabetes Intervention With Tea

Sponsor

Instituto Politécnico de Bragança (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05583045

Collaborator

Unidade Local de Saúde do Nordeste (Other), European Social Fund (Other)

140

Enrollment

Location

Arms

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Pre Diabetes	Other: Olive Leaf Tea Behavioral: Lifestyle behavior change program (LBC) Other: Placebo tea	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 programParticipants will be divided into two groups (A or B):A: Olive leaf tea + Lifestyle behavior change program B: Placebo tea + Lifestyle behavior change program

Masking:

Quadruple (Participant, Care Provider, 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.

Primary Purpose:

Prevention

Official Title:

PREVENT - Prediabetes Intervention With Olive Leaf Tea

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Fasting Plasma Glicose [12 weeks]
Effect of olive leaf tea (OLT) on FPG 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
Alkaline Phosphatase [12 weeks]
Effect of olive leaf tea (OLT) on Alkaline Phosphatase 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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