Circadian RhythmPistaSleepNCT07651605
Pistacho and Sleep Quality
A study testing Pistacho supplementation in people with Circadian Rhythm, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm
- What is being tested?
- Pistacho supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 13 Sep 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No diagnosed diseases
- Not regularly taking medications that affect melatonin synthesis or body regulation.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de Querétaro
Querétaro City, Querétaro, 76000
About this study
Official title: 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?
Read the 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.
- Conditions
- Circadian Rhythm
- Being tested
- Pistacho supplementation
- Keywords
- Chrononutrition, circadian clock, sleep, pistachio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pistacho supplementationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pistacho supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2 weeks, 4 weeks
Waist circumference
Waist circumference (WC, in cm) was measured using an ergonomic SECA 201 measuring tape.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 2 weeks, 4 weeks
Physical activity questionnaire (IPAQ)
Measured with the scale MET-minutes per week" (o MET-min/week)
Measured: Baseline, 2 weeks, 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
Cumulative score scale by Gobal PSQI score
Measured: Baseline, 2 weeks, 4 weeks
Secondary outcomes (3)
Concentration of metabolic and lipid parameters
Metabolic parameters, including glucose (mg/dL), cholesterol (HDL-c and LDL-c, mg/dL), and triglycerides (mg/dL).
Measured: 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.
Measured: 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."
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start13 Sep 2021
- Primary completion26 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A 28-day, uncontrolled, base-final intervention study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocio Campos-Vega, Universidad Autonoma de Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651605
- Sponsor's protocol ID
- CBFM-NOV19
- Acronym
- PistaSleep
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pistachio (Pistacia Vera L.) Consumption on Locomotor Activity and Molecular Regulation of the Circadian Clock in Adipose Tissue of Overweight Adults
- ClinicalTrials.gov ID
- NCT07651605
- Acronym / sponsor ID
- PistaSleep / CBFM-NOV19
- Conditions
- Circadian Rhythm
- Keywords
- Chrononutrition, circadian clock, sleep, pistachio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 28-day, uncontrolled, base-final intervention study
| Arm | Type | Receives |
|---|---|---|
| Pistacho consumption | Experimental | Other: Pistacho supplementationParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No diagnosed diseases
- Not regularly taking medications that affect melatonin synthesis or body regulation.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pistacho supplementationParticipants 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 | Other | Pistacho consumption |
Primary outcome
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).
Waist circumference
Time frame: Baseline, 2 weeks, 4 weeks
Waist circumference (WC, in cm) was measured using an ergonomic SECA 201 measuring tape.
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.
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.
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
Physical activity questionnaire (IPAQ)
Time frame: Baseline, 2 weeks, 4 weeks
Measured with the scale MET-minutes per week" (o MET-min/week)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 weeks, 4 weeks
Cumulative score scale by Gobal PSQI score
3 secondary outcomes
Concentration of metabolic and lipid parameters
Time frame: Baseline, 2 weeks, 4 weeks
Plasma antioxidant activity by FRAP method
Time frame: Baseline, 2 weeks, 4 weeks
Plasma antioxidant activity by ORAC assay.
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistacho supplementation in people with Circadian Rhythm, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition analysis (time frame: Baseline, 2 weeks, 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.