Pilot Trial of Hibiscus Drink During Pregnancy (PTHDDP)

NCT ID: NCT07175597

Last Updated: 2025-09-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-06-30

Brief Summary

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The goal of this phase I pilot clinical trial is to evaluate the acceptability, tolerability and effect on blood pressure and biomarkers of Hibiscus sabdariffa drink in pregnant women in the second trimester of pregnancy. The main questions it aims to answer are:

Is the drink acceptable to take as a daily dose for a long time? Does drinking the beverage cause negative effects? What is the effect of drink consumption on blood pressure and biomarkers in pregnant women?

Each participant was their own control with the values measured before consumption of the beverage and after four weeks of consumption.

The participants:

* Took a daily dose of the beverage for 4 weeks
* Once a week for the four weeks, they answered the acceptability and tolerability questionnaires
* Before starting to consume the beverage and after the 4 weeks of consumption, they had their blood pressure measured, and samples taken for biomarker measurements.

Detailed Description

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Conditions

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Pregnant Woman

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Four-week phase I pilot trial where participants are their own controls with pre- and post-treatment measurements
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

This trial included only one group, assessing the acceptability and tolerability of a beverage, as well as its effects on markers. The results will be used to promote a study with a larger number of participants and a longer timeframe.

Study Groups

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Pregnant women

Pregnant women in the second trimester of pregnancy who consumed a daily dose of Hibiscus sabdariffa drink for 4 weeks

Group Type EXPERIMENTAL

Hibiscus sabdariffa drink

Intervention Type DIETARY_SUPPLEMENT

A daily dose of Hibiscus sabdariffa drink that provides 9.6 mg of anthocyanins

Interventions

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Hibiscus sabdariffa drink

A daily dose of Hibiscus sabdariffa drink that provides 9.6 mg of anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Women in the second trimester of pregnancy (14 to 28 gestation weeks)
* Age 18 to 35 years
* Blood pressure \<140/90 mmHg

Exclusion Criteria

* Multiple or high-risk pregnancy
* Hypertensive disorder in previous pregnancies
* Body mass index \>32 kg/m2
* Present chronic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Polytechnic Institute, Mexico

OTHER

Sponsor Role collaborator

Victor Eduardo Alcantar Rodríguez

OTHER

Sponsor Role lead

Responsible Party

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Victor Eduardo Alcantar Rodríguez

Associate Research Professor B

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Victor E. Alcantar Rodríguez, PhD Student

Role: PRINCIPAL_INVESTIGATOR

National Polytechnic Institute and Autonomous University of Barcelona

Locations

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MEDOMAI

Cuernavaca, Morelos, Mexico

Site Status

Countries

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Mexico

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IPNMexico

Identifier Type: -

Identifier Source: org_study_id

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