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Completed

NCT Number: NCT07651605

Pistacho and Sleep Quality

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?

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Key information

Conditions

Circadian Rhythm

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autónoma de Querétaro

Querétaro City, Querétaro, 76000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pistacho supplementation

Other

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

Primary outcomes

  1. Body composition analysis

    Time frame: 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).

  2. Waist circumference

    Time frame: Baseline, 2 weeks, 4 weeks

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

  3. Plasma melatonin

    Time frame: 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.

  4. Circadian locomotor activity

    Time frame: 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.

  5. Questionnaire of activity during the day

    Time frame: Baseline, 2 weeks, 4 weeks

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

  6. Physical activity questionnaire (IPAQ)

    Time frame: Baseline, 2 weeks, 4 weeks

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

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 2 weeks, 4 weeks

    Cumulative score scale by Gobal PSQI score

Secondary outcomes

  1. Concentration of metabolic and lipid parameters

    Time frame: Baseline, 2 weeks, 4 weeks

    Metabolic parameters, including glucose (mg/dL), cholesterol (HDL-c and LDL-c, mg/dL), and triglycerides (mg/dL).

  2. Plasma antioxidant activity by FRAP method

    Time frame: 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.

  3. Plasma antioxidant activity by ORAC assay.

    Time frame: Baseline, 2 weeks, 4 weeks

    The antioxidant activity in deproteinized plasma was assessed using the oxygen radical absorbance capacity (ORAC) method."

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Queretaro

Other

Registry information

Official study title

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

Acronym: PistaSleep

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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