Prediabetes Intervention With Tea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Diabetes Mellitus, Type 2 Pre Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be divided into two groups (A or B):

A: Olive leaf tea + Lifestyle behavior change program B: Placebo tea + Lifestyle behavior change program

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Olive Leaf Tea (OLT)

Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program.

Group Type EXPERIMENTAL

Olive Leaf Tea

Intervention Type OTHER

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

Lifestyle behavior change program (LBC)

Intervention Type 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 tea (CON)

Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program

Group Type PLACEBO_COMPARATOR

Lifestyle behavior change program (LBC)

Intervention Type 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 tea

Intervention Type OTHER

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

Interventions

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Olive Leaf Tea

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

Intervention Type OTHER

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)

Intervention Type BEHAVIORAL

Placebo tea

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No