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Prediabetes Intervention With Tea (PREVENT)

Primary Purpose

Diabetes Mellitus, Type 2, Pre Diabetes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Olive Leaf Tea
Lifestyle behavior change program (LBC)
Placebo tea
Sponsored by
Instituto Politécnico de Bragança
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Olive leaves, Diabetes, Glycaemic control, Insulin resistance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Politécnico de Bragança

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olive Leaf Tea (OLT)

Placebo tea (CON)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fasting Plasma Glicose
Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes
Insulin
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
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)
Effect of olive leaf tea (OLT) on AST and ALT after 12 weeks of intervention in individuals with prediabetes
Alkaline Phosphatase
Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes
Bilirubin
Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes
Creatinine
Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes

Full Information

First Posted
October 13, 2022
Last Updated
October 17, 2022
Sponsor
Instituto Politécnico de Bragança
Collaborators
Unidade Local de Saúde do Nordeste, European Social Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05583045
Brief Title
Prediabetes Intervention With Tea
Acronym
PREVENT
Official Title
PREVENT - Prediabetes Intervention With Olive Leaf Tea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Politécnico de Bragança
Collaborators
Unidade Local de Saúde do Nordeste, European Social Fund

4. Oversight

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
Data Monitoring Committee
No

5. 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.
Detailed Description
This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Pre Diabetes
Keywords
Olive leaves, Diabetes, Glycaemic control, Insulin resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 program
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olive Leaf Tea (OLT)
Arm Type
Experimental
Arm Description
Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program.
Arm Title
Placebo tea (CON)
Arm Type
Placebo Comparator
Arm Description
Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program
Intervention Type
Other
Intervention Name(s)
Olive Leaf Tea
Intervention Description
Olive leaf tea (individual tea bags provided to participants with instructions of preparation)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle behavior change program (LBC)
Intervention Description
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
Other
Intervention Name(s)
Placebo tea
Intervention Description
Placebo tea containing 2,6g cellulose and a caramel coloring
Primary Outcome Measure Information:
Title
HbA1c
Description
Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting Plasma Glicose
Description
Effect of olive leaf tea (OLT) on FPG after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Title
Insulin
Description
Effect of olive leaf tea (OLT) on Insulin after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Title
Cholesterol Total, c-HDL, c-LDL and triglycerides
Description
Effect of olive leaf tea (OLT) on CT, c-HDL, c-LDL and TG after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Title
Aspartate transaminase (AST) and Alanine transaminase (ALT)
Description
Effect of olive leaf tea (OLT) on AST and ALT after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Title
Alkaline Phosphatase
Description
Effect of olive leaf tea (OLT) on Alkaline Phosphatase after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Title
Bilirubin
Description
Effect of olive leaf tea (OLT) on Bilirubin after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks
Title
Creatinine
Description
Effect of olive leaf tea (OLT) on Creatinine after 12 weeks of intervention in individuals with prediabetes
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuela Meireles, PhD
Organizational Affiliation
Instituto Politécnico de Bragança
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Politécnico de Bragança
City
Bragança
ZIP/Postal Code
5300-146
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Prediabetes Intervention With Tea

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