Pilot Trial of Hibiscus Drink During Pregnancy (PTHDDP)

NCT07175597 | Completed

• 1 other identifier: IPNMexico
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnant Woman

Keywords

Functional foods; Hibiscus sabdariffa drink; Pilot 1 clinical trial; Hypertension; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Acceptability of Hibiscus sabdariffa drink

  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: 1. I dislike it a lot 2. I dislike it moderately 3. I dislike it a little 4. I neither like it nor dislike it 5. I like it a little 6. I like it moderately 7. I like it a lot

  4 weeks

• Tolerability of Hibiscus sabdariffa Drink

  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: 1. Symptom absent 2. Symptom present but not bothersome 3. Symptom present and somewhat bothersome, but does not interfere with daily activities or sleep 4. Symptom present and bothersome because it interferes with daily activities or sleep 5. Required medical attention

  4 weeks

Secondary Outcomes (6)

• Blood pressure

  4 weeks

• Biomarkers glucose

  4 weeks

• Biomarkers cholesterol

  4 weeks

• Biomarkers triglycerides

  4 weeks

• Biomarkers creatinine

  4 weeks

Study Arms (1)

Pregnant women

EXPERIMENTAL

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

Dietary Supplement: Hibiscus sabdariffa drink

Interventions

Hibiscus sabdariffa drink DIETARY_SUPPLEMENT

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

Pregnant women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Victor Eduardo Alcantar Rodríguez: lead
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

MEDOMAI

Cuernavaca, Morelos, 62280, Mexico

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Victor E. Alcantar Rodríguez, PhD Student

  National Polytechnic Institute and Autonomous University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research Professor B

Model Details: Four-week phase I pilot trial where participants are their own controls with pre- and post-treatment measurements

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 16, 2025
• Study Start: April 30, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

ME (1)