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Pistacho and Sleep Quality (PistaSleep)

10. juni 2026 opdateret af: Rocio Campos-Vega, Universidad Autonoma de Queretaro

Effect of Pistachio (Pistacia Vera L.) Consumption on Locomotor Activity and Molecular Regulation of the Circadian Clock in Adipose Tissue of Overweight Adults

The goal of this study is to evaluate the effect of pistachio (Pistacia vera L.) consumption on plasma melatonin, antioxidant capacity, and circadian rhythms in overweight young adults.

The main question it aims to answer are:

  • Can the consumption of pistachios, specifically their content of compounds like phyto-melatonin, effectively regulate the human biological clock and circadian rhythms?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will provide scientific evidence supporting the biological clock-regulating action of compounds present in pistachios, such as phyto-melatonin, their impact on circadian rhythm regulation, and improvement of metabolic processes altered during obesity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76000
        • Universidad Autónoma de Querétaro

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • No diagnosed diseases
  • Not regularly taking medications that affect melatonin synthesis or body regulation.

Exclusion Criteria:

  • Smokers
  • Pregnant women
  • Individuals with night shifts, those following special diets or taking weight loss supplements
  • People who had undergone recent surgical procedures or significant weight loss in two months before the study.
  • Those taking sleep medications.
  • Individuals who had made trans meridian trips within 1 month of the evaluation,
  • Individuals with allergies, intolerances, or aversions to nuts/pistachios
  • Participants who voluntarily withdrew from the study
  • Participants who tested positive for COVID-19 during the intervention
  • Participants who experienced adverse effects.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pistacho consumption
Participants consumed 28 g (equivalent to 5.6 mg of phytomelatonin) of pistachios each day, specifically 40 pistachios with shells, 1 hour to 30 minutes before bedtime.
Andet: Pistacho supplementation
Participants consumed 28 g (equivalent to 5.6 mg of phyto-melatonin) of pistachios each day, specifically 40 pistachios with shells, 1 hour to 30 minutes before bedtime

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body composition analysis
Tidsramme: Baseline, 2 weeks, 4 weeks
Body composition analysis (BCA, including fat mass [FM] and fat-free mass [FFM], in kg and %) was performed with a seca mBCA 514/515 medical Body Composition Analyzer (Allers Hamburg, Germany). The measurements were conducted in accordance with the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK).
Baseline, 2 weeks, 4 weeks
Waist circumference
Tidsramme: Baseline, 2 weeks, 4 weeks
Waist circumference (WC, in cm) was measured using an ergonomic SECA 201 measuring tape.
Baseline, 2 weeks, 4 weeks
Plasma melatonin
Tidsramme: Baseline, 2 weeks, 4 weeks
Plasma obtained from the same samples of biochemicals determinations. Plasma melatonin levels were measured before and after the intervention using a commercial plasma melatonin kit.
Baseline, 2 weeks, 4 weeks
Circadian locomotor activity
Tidsramme: Through study completion during 28-days.
A temperature sensor on the wirst, an activity and body position sensor was placed on the participant's arm and a luxometer was worn on the neck with a pendant over the clothing.
Through study completion during 28-days.
Questionnaire of activity during the day
Tidsramme: Baseline, 2 weeks, 4 weeks
Horne and Östberg morning- evening test. Visual Analog Score with a cumulative score scale
Baseline, 2 weeks, 4 weeks
Physical activity questionnaire (IPAQ)
Tidsramme: Baseline, 2 weeks, 4 weeks
Measured with the scale MET-minutes per week" (o MET-min/week)
Baseline, 2 weeks, 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline, 2 weeks, 4 weeks
Cumulative score scale by Gobal PSQI score
Baseline, 2 weeks, 4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concentration of metabolic and lipid parameters
Tidsramme: Baseline, 2 weeks, 4 weeks
Metabolic parameters, including glucose (mg/dL), cholesterol (HDL-c and LDL-c, mg/dL), and triglycerides (mg/dL).
Baseline, 2 weeks, 4 weeks
Plasma antioxidant activity by FRAP method
Tidsramme: Baseline, 2 weeks, 4 weeks
The antioxidant activity in deproteinized plasma was assessed using the ferric reducing antioxidant power (FRAP) assay. Plasma antioxidant activity was measured as milimol equivalent of Trolox/mL.
Baseline, 2 weeks, 4 weeks
Plasma antioxidant activity by ORAC assay.
Tidsramme: Baseline, 2 weeks, 4 weeks
The antioxidant activity in deproteinized plasma was assessed using the oxygen radical absorbance capacity (ORAC) method."
Baseline, 2 weeks, 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Autonoma de Queretaro

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)

13. september 2021

Primær færdiggørelse (Faktiske)

26. september 2021

Studieafslutning (Faktiske)

1. november 2021

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CBFM-NOV19

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Døgnrytme

Kliniske forsøg med Pistacho supplementation

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