Effect of Hibiscus and Lippia Extract on Blood Pressure
Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers
1 other identifier
interventional
51
1 country
1
Brief Summary
Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a dietetic intervention and physical exercise, supplemented with a polyphenolic extract, decreases blood pressure in hypertensive volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2018
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedSeptember 4, 2020
September 1, 2020
1 year
March 16, 2018
September 3, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in Blood Pressure Measurement with respect to baseline
Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats)
Continuous measurements for 24 hours, 1 day per week, total 6 weeks
Changes in Blood Pressure Measurement with respect to baseline
Single Blood Pressure measurements, using the Omron M6 Comfort device
One measurement per day, 1 day per week, total 6 weeks
Secondary Outcomes (12)
Total Cholesterol
At the beginning and end of the intervention, total 6 weeks
HDL Cholesterol
At the beginning and end of the intervention, total 6 weeks
LDL Cholesterol
At the beginning and end of the intervention, total 6 weeks
Triglycerides
At the beginning and end of the intervention, total 6 weeks
Glucose
At the beginning and end of the intervention, total 6 weeks
- +7 more secondary outcomes
Study Arms (2)
Placebo Control
PLACEBO COMPARATOR2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks.
Dietetic Supplement Group
EXPERIMENTAL2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure
You may not qualify if:
- Minors (under 18 years of age)
- volunteers with high cardiovascular disease risk
- pharmacological treatment for blood pressure
- presence of any chronic disease/condition
- known allergies regarding the supplement and/or placebo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Miguel Hernandez de Elchelead
- Hospital General Universitario Elchecollaborator
- Monteloeder SLcollaborator
Study Sites (1)
Universidad Miguel Hernandez de Elche
Elche, Alicante, 03202, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 16, 2018
First Posted
April 24, 2018
Study Start
March 26, 2018
Primary Completion
April 1, 2019
Study Completion
April 15, 2019
Last Updated
September 4, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share