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Completed

NCT Number: NCT07175597

Pilot Trial of Hibiscus Drink During Pregnancy (PTHDDP)

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.

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Key information

Conditions

Pregnant Woman Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MEDOMAI

Cuernavaca, Morelos, 62280, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hibiscus sabdariffa drink

Dietary Supplement

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

Primary outcomes

  1. Acceptability of Hibiscus sabdariffa drink

    Time frame: 4 weeks

    Beverage acceptability was measured using a sensory evaluation with 7-point hedonic scale of the attributes of odor, color, flavor, mouthfeel, aftertaste, and overall appearance through questionnaires applied once a week for 4 weeks.

    The outcome measures are based on a 7-point hedonic scale where every participant can answer in every attribute evaluated:

    • I dislike it a lot
    • I dislike it moderately
    • I dislike it a little
    • I neither like it nor dislike it
    • I like it a little
    • I like it moderately
    • I like it a lot

  2. Tolerability of Hibiscus sabdariffa Drink

    Time frame: 4 weeks

    Tolerability was measured by the presence or absence of gastrointestinal symptoms such as nausea, regurgitation, vomiting, constipation, diarrhea, flatulence, and abdominal pain through questionnaires applied once a week for 4 weeks.

    The outcome measures for the tolerability assessment were the presence or absence of gastrointestinal symptoms mentioned in the previous paragraph, where participants had the option to respond:

    • Symptom absent
    • Symptom present but not bothersome
    • Symptom present and somewhat bothersome, but does not interfere with daily activities or sleep
    • Symptom present and bothersome because it interferes with daily activities or sleep
    • Required medical attention

Secondary outcomes

  1. Blood pressure

    Time frame: 4 weeks

    Blood pressure was measured using the Korotkoff auscultation method, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.

    The outcome measures were the average of the measurements of the 10 participants expressed as mm/Hg of systolic and diastolic pressure.

  2. Biomarkers glucose

    Time frame: 4 weeks

    Glucose was measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.

    The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.

  3. Biomarkers cholesterol

    Time frame: 4 weeks

    Cholesterol was measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.

    The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.

  4. Biomarkers triglycerides

    Time frame: 4 weeks

    Triglycerides were measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.

    The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.

  5. Biomarkers creatinine

    Time frame: 4 weeks

    Creatinine was measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.

    The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.

  6. Biomarkers proteinuria

    Time frame: 4 weeks

    Participants were also asked to provide a urine sample to determine proteinuria.

    These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.

    The results were presented as the number of positive cases for proteinuria, as well as the average of positive cases expressed as mg/dL.

Sponsors and collaborators

Lead sponsor

Victor Eduardo Alcantar Rodríguez

Other

Collaborators

  • National Polytechnic Institute, Mexico

Registry information

Official study title

Trial of Acceptability, Tolerability and Biochemical Indicators of Hibiscus Sabdariffa L. Drink in Pregnant Women

Acronym: PTHDDP

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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