NCT05583045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 13, 2022

Last Update Submit

October 17, 2022

Conditions

Diabetes Mellitus, Type 2Pre Diabetes

Keywords

Olive leavesDiabetesGlycaemic controlInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • HbA1c

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

    12 weeks

Secondary Outcomes (7)

  • Fasting Plasma Glicose

    12 weeks

  • Insulin

    12 weeks

  • Cholesterol Total, c-HDL, c-LDL and triglycerides

    12 weeks

  • Aspartate transaminase (AST) and Alanine transaminase (ALT)

    12 weeks

  • Alkaline Phosphatase

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Olive Leaf Tea (OLT)

EXPERIMENTAL

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

Other: Olive Leaf TeaBehavioral: Lifestyle behavior change program (LBC)

Placebo tea (CON)

PLACEBO COMPARATOR

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

Behavioral: Lifestyle behavior change program (LBC)Other: Placebo tea

Interventions

Olive Leaf TeaOTHER

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

Olive Leaf Tea (OLT)
Lifestyle behavior change program (LBC)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)

Olive Leaf Tea (OLT)Placebo tea (CON)
Placebo teaOTHER

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

Placebo tea (CON)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Politécnico de Bragança

Bragança, 5300-146, Portugal

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose IntoleranceDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaHyperinsulinism

Study Officials

  • Manuela Meireles, PhD

    Instituto Politécnico de Bragança

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 17, 2022

Study Start

November 1, 2022

Primary Completion

March 1, 2023

Study Completion

July 1, 2023

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

All participant data will be collected anonymously and only individual data related to the outcomes will be available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the publication of the final results during two years
Access Criteria
Will be available upon request to researcher

Locations

PT(1)