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| Name | Class |
|---|---|
| National Polytechnic Institute, Mexico | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Experimental | Pregnant women in the second trimester of pregnancy who consumed a daily dose of Hibiscus sabdariffa drink for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hibiscus sabdariffa drink | Dietary Supplement | A daily dose of Hibiscus sabdariffa drink that provides 9.6 mg of anthocyanins |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor E. Alcantar RodrÃguez, PhD Student | National Polytechnic Institute and Autonomous University of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEDOMAI | Cuernavaca | Morelos | 62280 | Mexico |
A platform will be sought to publish the results databases.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2024 | Sep 9, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2024 | Sep 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Four-week phase I pilot trial where participants are their own controls with pre- and post-treatment measurements
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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.
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| Biomarkers glucose |
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. |
| 4 weeks |
| Biomarkers cholesterol | 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 weeks |
| Biomarkers triglycerides | 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. | 4 weeks |
| Biomarkers creatinine | 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. | 4 weeks |
| Biomarkers proteinuria | 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. | 4 weeks |