Efficacy of a Natural Ingredient on Blood Pressure (FISTA)
3. Oktober 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
80
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Murcia, Spanien, 30107
- Catholic University of Murcia
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Assessing a change of blood pressure five times
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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body composition
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. April 2018
Primärer Abschluss (Tatsächlich)
28. Februar 2019
Studienabschluss (Tatsächlich)
30. März 2019
Studienanmeldedaten
Zuerst eingereicht
27. Februar 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. März 2018
Zuerst gepostet (Tatsächlich)
20. März 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Oktober 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Oktober 2019
Zuletzt verifiziert
1. Oktober 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UCAM-CFE-0001
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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