Blood PressureNCT03507023
Effect of Hibiscus and Lippia Extract on Blood Pressure
A study testing Metabolaid® in people with Blood Pressure, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Metabolaid®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers
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.
Read the detailed description
Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs.
Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.
- Conditions
- Blood Pressure
- Being tested
- Metabolaid®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolaid®Dietary supplement
500 mg per day, in fasting conditions.
PlaceboDietary supplement
500 mg per day, in fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | 2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks. Receives: Dietary Supplement: Placebo |
| Dietetic Supplement Group | Experimental | 2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks. Receives: Dietary Supplement: Metabolaid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Pressure Measurement with respect to baseline
Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats)
Measured: 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
Measured: One measurement per day, 1 day per week, total 6 weeks
Secondary outcomes (12)
Total Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning and end of the intervention, total 6 weeks
HDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning and end of the intervention, total 6 weeks
LDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning and end of the intervention, total 6 weeks
Triglycerides
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning and end of the intervention, total 6 weeks
Glucose
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning and end of the intervention, total 6 weeks
Weight, using a weight scale
In kg
Measured: Once a week, for 6 weeks
Height, using measuring tape
in cm
Measured: Once a week, for 6 weeks
BMI, calculated based on Weight and Height
in kg/m^2
Measured: Once a week, for 6 weeks
Waist Circumference, using a measuring tape
in cm
Measured: Once a week, for 6 weeks
Hip Circumference, using a measuring tape
in cm
Measured: Once a week, for 6 weeks
Waist/Hip Ratio
Calculated as indicator of obesity, based on Waist and Hip Circumference measurements
Measured: Once a week, for 6 weeks
Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire
Subjective assessment of physical activity using a validated questionnaire
Measured: At baseline, 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start26 Mar 2018
- Primary completion1 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Elche, Monteloeder SL
- Responsible party
- Principal investigator, María Herranz-Lopez, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507023
- Sponsor's protocol ID
- UniversidadMHE_Met
- Status last verified
- Sep 2020
- First submitted
- 16 Mar 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers
- ClinicalTrials.gov ID
- NCT03507023
- Acronym / sponsor ID
- UniversidadMHE_Met
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Hospital General Universitario Elche, Monteloeder SL
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs.
Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: Placebo2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks. |
| Dietetic Supplement Group | Experimental | Dietary Supplement: Metabolaid®2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolaid®500 mg per day, in fasting conditions. | Dietary supplement | Dietetic Supplement Group |
| Placebo500 mg per day, in fasting conditions. | Dietary supplement | Placebo Control |
Primary outcome
Changes in Blood Pressure Measurement with respect to baseline
Time frame: Continuous measurements for 24 hours, 1 day per week, total 6 weeks
Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats)
Changes in Blood Pressure Measurement with respect to baseline
Time frame: One measurement per day, 1 day per week, total 6 weeks
Single Blood Pressure measurements, using the Omron M6 Comfort device
12 secondary outcomes
Total Cholesterol
Time frame: At the beginning and end of the intervention, total 6 weeks
HDL Cholesterol
Time frame: At the beginning and end of the intervention, total 6 weeks
LDL Cholesterol
Time frame: At the beginning and end of the intervention, total 6 weeks
Triglycerides
Time frame: At the beginning and end of the intervention, total 6 weeks
Glucose
Time frame: At the beginning and end of the intervention, total 6 weeks
Weight, using a weight scale
Time frame: Once a week, for 6 weeks
Height, using measuring tape
Time frame: Once a week, for 6 weeks
BMI, calculated based on Weight and Height
Time frame: Once a week, for 6 weeks
Waist Circumference, using a measuring tape
Time frame: Once a week, for 6 weeks
Hip Circumference, using a measuring tape
Time frame: Once a week, for 6 weeks
Waist/Hip Ratio
Time frame: Once a week, for 6 weeks
Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire
Time frame: At baseline, 3 and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolaid® in people with Blood Pressure, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Pressure Measurement with respect to baseline (time frame: Continuous measurements for 24 hours, 1 day per week, total 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.