- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Cicero J Benjamim, PhD student
- Telefonnummer: +5587 88621194
- E-post: jonasbenjamim@usp.br
Studiesteder
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Ceará
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Juazeiro do Norte, Ceará, Brasil, 63020070
- Rekruttering
- Cicero Jonas Rodrigues Benjamim
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Ta kontakt med:
- Cicero Jonas R Benjamim
- Telefonnummer: 88997290435
- E-post: jonasbenjam1m@hotmail.com
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Hovedetterforsker:
- Milana Santana
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Hovedetterforsker:
- Cicero Benjamim
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 30 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: 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.
Andre navn:
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Eksperimentell: 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.
|
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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Heart rate variability
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Blood pressure
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2021
Primær fullføring (Forventet)
31. august 2021
Studiet fullført (Forventet)
31. august 2021
Datoer for studieregistrering
Først innsendt
30. april 2021
Først innsendt som oppfylte QC-kriteriene
30. april 2021
Først lagt ut (Faktiske)
6. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- x32
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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