Pistacho and Sleep Quality (PistaSleep)

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?

Study Overview

• Status: Completed
• Conditions: Circadian Rhythm
• Intervention / Treatment: Other: Pistacho supplementation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of metabolic and lipid parameters	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	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.	The antioxidant activity in deproteinized plasma was assessed using the oxygen radical absorbance capacity (ORAC) method."	Baseline, 2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Queretaro

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): September 26, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sleep; circadian clock; Chrononutrition; pistachio
• Other Study ID Numbers: CBFM-NOV19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No