Efficacy of a Natural Ingredient on Blood Pressure (FISTA)
3. oktober 2019 opdateret af: Francisco Javier López Román, Universidad Católica San Antonio de Murcia
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Murcia, Spanien, 30107
- Catholic University of Murcia
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ëxperimental
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. |
84 days of consumption
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Placebo komparator: Placebo
Consumption during 84 days of saccharose.
Two capsules a day will be consumed thirty minutes before breakfast for 84 days.
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84 days of consumption
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessing a change of blood pressure five times
Tidsramme: 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.
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blood pressure is measured with a holter
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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body composition
Tidsramme: 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
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Dual X-ray absorptiometry (DEXA)
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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
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body composition
Tidsramme: 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.
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Bioimpedancetry
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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.
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blood samples
Tidsramme: 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.
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Glucidal metabolism and lipid metabolism.
It was measured in milligrams per deciliter.
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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.
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Subjective sensation of product consumption
Tidsramme: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
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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.
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Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
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physical activity
Tidsramme: 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.
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accelerometer
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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.
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Control of dietary intake
Tidsramme: 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.
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Diet source
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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.
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quality of life questionnaire
Tidsramme: 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.
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questionnaire: WHOQOL-BREF
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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.
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Gastrointestinal well-being evaluation
Tidsramme: 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.
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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.
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. april 2018
Primær færdiggørelse (Faktiske)
28. februar 2019
Studieafslutning (Faktiske)
30. marts 2019
Datoer for studieregistrering
Først indsendt
27. februar 2018
Først indsendt, der opfyldte QC-kriterier
19. marts 2018
Først opslået (Faktiske)
20. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UCAM-CFE-0001
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