NCT05397509

Brief Summary

This study tests the effect of Olive Tea Ingestion in ameliorating glycemic response after a high-glycemic meal

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 29, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 31, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

May 25, 2022

Last Update Submit

May 25, 2022

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Area under the curve

    120 minutes

Study Arms (2)

Olive Leaf Tea

EXPERIMENTAL

Olive Leaf Tea

Other: Olive leaf tea

Placebo tea

PLACEBO COMPARATOR

Placebo tea

Other: Placebo tea

Interventions

Olive leaf teaOTHER

250 mL of Olive leaf tea and a high-glycemic breakfast

Olive Leaf Tea
Placebo teaOTHER

250 mL of placebo tea and a high-glycemic breakfast

Placebo tea

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details50 female- 50 male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • currently taking drugs interfering with glucose regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

escola Superior de Saúde

Bragança, 5300-253, Portugal

RECRUITING

Study Officials

  • Manuela Meireles, PhD

    Instituto Politécnico de Bragança

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Meireles, PhD

CONTACT

273330984manuela.meireles@ipb.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
olive leaf tea and placebo tea were offered in a opaque mug
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Each participant will test one beverage on the first visit and the other one on the second visit. A wash-out period of two weeks will be done. Allocation of the first beverage to each participant is made by randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

April 29, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

May 31, 2022

Record last verified: 2022-04

Locations

PT(1)