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- Klinische proef NCT04875143
Effects Of Acute Supplementation Of Citrus Aurantium L. On The Recovery Of Autonomic And Cardiovascular Activity After A Sub-Maximum Aerobic Exercise Session In Healthy Individuals
30 april 2021 bijgewerkt door: Cicero Jonas R Benjamim, University of Pernambuco
Effects Of Acute Supplementation Of Citrus Aurantium L. On The Recovery Of Autonomic And Cardiovascular Activity After A Submitted Aerobic Exercise Session In Healthy Individuals: A Prospective, Randomizado-Plato-Rudomizado Plado Study.
INTRODUCTION: Non-pharmacological interventions for the treatment of cardiovascular and metabolic disorders have been investigated.
In this context, Citrus aurantium L., popularly known as Bitter Orange, rich in synephrine (p-synephrine), a phenylethylaminic alkaloid that is present in the bitter orange peel, has been used as an adjunct in metabolic disorders.
Given the effects, the components of Citrus aurantium L. diverge from other thermogens by being able to activate metabolism and lipolysis without interfering with the performance of the cardiovascular system, making this an advantage for its use in diets.
In studies, it has been observed that the activation of β-3 receptors plays an important role in the regulation and activation of other receptors, modulating and, when they are stimulated in excess, and thus, it presents effects that in addition to not causing overload in the cardiovascular system.
OBJECTIVE: To evaluate the effect of supplementation of Citrus aurantium L. in combination with submaximal aerobic exercise on autonomic and cardiovascular parameters of physically active.
METHODOLOGY: This is a prospective, randomized, placebo-controlled, double-blind crossover trial.
40 physically active volunteers will participate in the study.
They will be qualified for the voluntary study of the male gender, who are aged between 18 and 30 years old and have a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m².
Do not use any medication that may interfere with cardiac autonomic modulation and do not have skeletal muscle damage.
They will be considered as exclusion criteria for clinical patients, as well as those who have already used anabolic steroids or who have cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures.
EXPECTED RESULTS: Speculated that the protective effects of flavonoids and their antioxidant properties found in Citrus aurantium L., optimize autonomic recovery after aerobic exercise.
In addition, HRV can be used to ascertain its SNA activation effects and validate the safety of the applicability of this supplement for overweight populations, considering that it is used for this purpose.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
40
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Cicero J Benjamim, PhD student
- Telefoonnummer: +5587 88621194
- E-mail: jonasbenjamim@usp.br
Studie Locaties
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Ceará
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Juazeiro do Norte, Ceará, Brazilië, 63020070
- Werving
- Cicero Jonas Rodrigues Benjamim
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Contact:
- Cicero Jonas R Benjamim
- Telefoonnummer: 88997290435
- E-mail: jonasbenjam1m@hotmail.com
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Hoofdonderzoeker:
- Milana Santana
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Hoofdonderzoeker:
- Cicero Benjamim
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 30 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- Male volunteers, aged between 18 and 30 years and with a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m² will be considered eligible for the study.
Exclusion Criteria:
- Smoking patients will be considered as exclusion criteria. As well as individuals with cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: PLACEBO
From a pre-established randomization, on the first day of collection, volunteers will be allocated to group I (Placebo) or group II (Citrus aurantium L.).
In the first intervention, the volunteers allocated to group I will take a capsule containing 500mg of starch, at the end of this, another capsule containing 500mg of Citrus aurantium L. will be provided for the second intervention.
Conversely, the volunteers allocated to group II will ingest a capsule containing 500mg of Citrus aurantium L. in the first intervention, and at the end of the experiment, another capsule containing 500mg of starch will be provided.
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In the first intervention, the volunteers allocated to group I will take a capsule containing 500mg of starch, at the end of this, another capsule containing 500mg of Citrus aurantium L. will be provided for the second intervention.
Andere namen:
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Experimenteel: Citrus aurantium L.
From a pre-established randomization, on the first day of collection, volunteers will be allocated to group I (Placebo) or group II (Citrus aurantium L.).
In the first intervention, the volunteers allocated to group I will take a capsule containing 500mg of starch, at the end of this, another capsule containing 500mg of Citrus aurantium L. will be provided for the second intervention.
Conversely, the volunteers allocated to group II will ingest a capsule containing 500mg of Citrus aurantium L. in the first intervention, and at the end of the experiment, another capsule containing 500mg of starch will be provided.
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In the first intervention, the volunteers allocated to group I will take a capsule containing 500mg of starch, at the end of this, another capsule containing 500mg of Citrus aurantium L. will be provided for the second intervention.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Heart rate variability
Tijdsspanne: through study completion, an average of 1 year
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Heart rate variability (HRV) is a non-invasive method that analyzes the autonomic regulation of heart rate in humans.
It is a conventionally accepted term to describe oscillations in the intervals between consecutive heartbeats (RR intervals), which are related to the influences of the ANS on the sinus node.
It is a non-invasive technique, whose analysis can be performed using linear methods, in the domain of time and frequency, and non-linear, in the domain of chaos
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through study completion, an average of 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Blood pressure
Tijdsspanne: through study completion, an average of 1 year
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Check the blood pressure of subjects with and without the ingestion of Citrus aurantium L. before and in the recovery period after physical exercise;
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through study completion, an average of 1 year
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 februari 2021
Primaire voltooiing (Verwacht)
31 augustus 2021
Studie voltooiing (Verwacht)
31 augustus 2021
Studieregistratiedata
Eerst ingediend
30 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
30 april 2021
Eerst geplaatst (Werkelijk)
6 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 mei 2021
Laatste update ingediend die voldeed aan QC-criteria
30 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- x32
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .