HypertensionFISTANCT03471533
Efficacy of a Natural Ingredient on Blood Pressure
A study testing nutraceutical: experimental product in people with Hypertension, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- nutraceutical: experimental product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2018to 30 Mar 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
- Subjects of both sexes between 18-65 years old.
- Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
- Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study
Who cannot join
- In pharmacological treatment of arterial hypertension.
- Subjects with acute diseases.
- Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
- Subjected to major surgery in the last 3 months.
- Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
- Subjects with allergies or eating disorders.
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- Participation in another study that includes blood extractions or dietary intervention.
- Pregnant woman.
- Subjects whose condition does not make them eligible for the study, according to the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial and Randomized Efficacy of a Natural Ingredient on the Arterial Tension of Normother Subjects or With Arterial Hypertension Grade i Without Pharmacological Treatment
Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. Later, a statistical analysis will be carried out with the variables measured in the study to obtain results.
- Conditions
- Hypertension
- Being tested
- nutraceutical: experimental product, placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutraceutical: experimental productDietary supplement
84 days of consumption
placeboDietary supplement
84 days of consumption
| Study group | Role | What they receive |
|---|---|---|
| Ëxperimental | Experimental | Consumption during 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg.
Two capsules a day will be consumed thirty minutes before breakfast for 84 days. Receives: Dietary Supplement: nutraceutical: experimental product |
| Placebo | Placebo comparator | Consumption during 84 days of saccharose. Two capsules a day will be consumed thirty minutes before breakfast for 84 days. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing a change of blood pressure five times
blood pressure is measured with a holter
Measured: Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.
Secondary outcomes (8)
body composition
Dual X-ray absorptiometry (DEXA)
Measured: Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end
body composition
Bioimpedancetry
Measured: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.
blood samples
Glucidal metabolism and lipid metabolism. It was measured in milligrams per deciliter.
Measured: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
Subjective sensation of product consumption
5-point hedonic scale. There are five points, being 1 I do not like and 5 I like it a lot. A scale will be passed through paper.
Measured: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
physical activity
accelerometer
Measured: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.
Control of dietary intake
Diet source
Measured: A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
quality of life questionnaire
questionnaire: WHOQOL-BREF
Measured: The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.
Gastrointestinal well-being evaluation
Gastrointestinal quality of life questionnaire. The subjects have to answer 36 items on a scale of one to five, being 1 all the time and 5 never.
Measured: The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start9 Apr 2018
- Primary completion28 Feb 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Model description
- Randomized, controlled clinical trial, with two parallel branches, (experimental product and placebo), double blind and unicentric.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471533
- Sponsor's protocol ID
- UCAM-CFE-0001
- Acronym
- FISTA
- Status last verified
- Oct 2019
- First submitted
- 27 Feb 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial and Randomized Efficacy of a Natural Ingredient on the Arterial Tension of Normother Subjects or With Arterial Hypertension Grade i Without Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT03471533
- Acronym / sponsor ID
- FISTA / UCAM-CFE-0001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 20 Mar 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.
Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. Later, a statistical analysis will be carried out with the variables measured in the study to obtain results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled clinical trial, with two parallel branches, (experimental product and placebo), double blind and unicentric.
| Arm | Type | Receives |
|---|---|---|
| Ëxperimental | Experimental | Dietary Supplement: nutraceutical: experimental productConsumption during 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules a day will be consumed thirty minutes before breakfast for 84 days. |
| Placebo | Placebo comparator | Dietary Supplement: placeboConsumption during 84 days of saccharose. Two capsules a day will be consumed thirty minutes before breakfast for 84 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of both sexes between 18-65 years old.
- Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
- Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study
Key exclusion criteria (9 listed)
- In pharmacological treatment of arterial hypertension.
- Subjects with acute diseases.
- Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
- Subjected to major surgery in the last 3 months.
- Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
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 |
|---|---|---|
| nutraceutical: experimental product84 days of consumption | Dietary supplement | Ëxperimental |
| placebo84 days of consumption | Dietary supplement | Placebo |
Primary outcome
Assessing a change of blood pressure five times
Time frame: Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.
blood pressure is measured with a holter
8 secondary outcomes
body composition
Time frame: Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end
body composition
Time frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.
blood samples
Time frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
Subjective sensation of product consumption
Time frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
physical activity
Time frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.
Control of dietary intake
Time frame: A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
quality of life questionnaire
Time frame: The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.
Gastrointestinal well-being evaluation
Time frame: The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.
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 Oct 2019.
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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 nutraceutical: experimental product in people with Hypertension, run by Universidad Católica San Antonio de Murcia 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 3 inclusion and 9 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 Oct 2019. 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?
Assessing a change of blood pressure five times (time frame: Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.). 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 Oct 2019.