NCT07651605

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

13 days

First QC Date

June 1, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Chrononutritioncircadian clocksleeppistachio

Outcome Measures

Primary Outcomes (7)

  • Body composition analysis

    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

    Waist circumference (WC, in cm) was measured using an ergonomic SECA 201 measuring tape.

    Baseline, 2 weeks, 4 weeks

  • Plasma melatonin

    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

    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

    Horne and Östberg morning- evening test. Visual Analog Score with a cumulative score scale

    Baseline, 2 weeks, 4 weeks

  • Physical activity questionnaire (IPAQ)

    Measured with the scale MET-minutes per week" (o MET-min/week)

    Baseline, 2 weeks, 4 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    Cumulative score scale by Gobal PSQI score

    Baseline, 2 weeks, 4 weeks

Secondary Outcomes (3)

  • Concentration of metabolic and lipid parameters

    Baseline, 2 weeks, 4 weeks

  • Plasma antioxidant activity by FRAP method

    Baseline, 2 weeks, 4 weeks

  • Plasma antioxidant activity by ORAC assay.

    Baseline, 2 weeks, 4 weeks

Study Arms (1)

Pistacho consumption

EXPERIMENTAL

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.

Other: Pistacho supplementation

Interventions

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

Pistacho consumption

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autónoma de Querétaro

Querétaro City, Querétaro, 76000, Mexico

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: A 28-day, uncontrolled, base-final intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full-time research professor.

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 16, 2026

Study Start

September 13, 2021

Primary Completion

September 26, 2021

Study Completion

November 1, 2021

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations