Pregnant Woman
Conditions
Keywords
Functional foods, Hibiscus sabdariffa drink, Pilot 1 clinical trial, Hypertension, Biomarkers
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.
Interventions
DIETARY_SUPPLEMENTHibiscus sabdariffa drink
A daily dose of Hibiscus sabdariffa drink that provides 9.6 mg of anthocyanins
Sponsors
National Polytechnic Institute, Mexico
Victor Eduardo Alcantar Rodríguez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
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.
Intervention model description
Four-week phase I pilot trial where participants are their own controls with pre- and post-treatment measurements
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Hibiscus sabdariffa drink | 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: 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 |
| Tolerability of Hibiscus sabdariffa Drink | 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: 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers cholesterol | 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. |
| Biomarkers triglycerides | 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. |
| Blood pressure | 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. |
| Biomarkers proteinuria | 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. |
| Biomarkers creatinine | 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. |
| Biomarkers glucose | 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. |
Countries
Mexico
Outcome results
None listed