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CompletedNCT03059576MTRUpdated Mar 27, 2017

Circadian System Heritability Assessed in Free Living Conditions

An observational study in Healthy, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Universidad de Murcia · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
106
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

The purpose of this investigation is to assess the role of the genetic and environmental factor on circadian system, in free living conditions by the use of a female twin population. With the results from this study, the investigators expect to advance in the understanding of the role of the endogenicity of the circadian system variables such as temperature, activity, sleep and timing of food intake as the main cause of the coincidence of the rhythms. However, the investigators expected that some parameters are still dependent on environment to a relevant extent and, hence, amenable to change through external interventions.

Read the detailed description

Twin studies are a classic in the analysis of the relative contribution of genetic and environmental factors to behavior and other phenotypes. These models are most often used to separate genetic from environmental causes in the family resemblance methodology. These models based on twins have been previously carried out in chronobiology. In fact, during the years 1993 and 1994, Paul Linkowski et al., performed two relevant studies on the circadian system to analyze the relative contributions of hereditary and/or environmental factors of cortisol secretion and blood pressure, respectively, and concluded that genetic factors control some of the characteristics of cortisol and diastolic blood pressure circadian rhythmicity. The heritability of other circadian markers has also demonstrated such as morningness- eveningness (44%), sleep-related variables have also pointed to a relevant role of genetics with heritability estimates of sleep duration between 17% and 55%. However, to the investigators knowledge, the heritability of other relevant chronobiological markers, measured in free living conditions such as body temperature, actigraphy and sleep has not been studied.

These goals will be achieved through a specific approach:

  • Observational (Aim 1): To study the potential effect of the genetic and environmental factor in the circadian system health in order to improve the chronobiological therapies in the clinical practice (n=106).
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Conditions studied

  • Healthy

Keywords

  • Chronobiology
  • Circadian rhythms
  • Heritability
  • Twins
03

In context

Lead sponsor

Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

All participants are voluntarily in the Murcia Twin Register in Spain. All participants are from the Spanish city of Murcia, located on the Southeast coast of the Mediterranean Sea.

Eligibility criteria

IInclusion Criteria:

  • Body Mass Index: >19 kg/m2
  • Age: between 18 and 70 year of age
  • Caucasian

Exclusion Criteria:

  • Receiving treatment with thermogenic, lipogenic, or contraceptive drugs
  • Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
  • Bulimia diagnosis, prone to binge eating
  • Undergoing treatment with anxiolytic or antidepressant drugs
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
106 participants (actual)
Patient registry
No

Interventions

  • OtherChronobiological status of the subjects

    Participation was completely voluntary and not remunerated. The subjects were organized into groups of 5 pairs, and were given an appointment at a university facility located in the city center, where informed consent was signed prior to the procedures indicated below. An informational letter was sent to pre-selected individuals. Later a phone call confirmed their availability. * Temperature rhythm was assessed continuously for 7 days using a temperature sensor and programmed to collect information every 10 min. * Body position and rest-activity rhythm were assessed over the same 7 days using a Acceleration Data Logger that record data every min and placed on the non-dominant arm by means of an elastic band, with its X axis parallel to the humerus bone. * Diet and sleep record were completed over the same week, their sleep schedules and their nutritional status.

06

What researchers measure

Primary outcomes

  1. Temperature record

    Measured using temperature sensor

    Time frame: Total of 1 week between Visit 1 and 2

  2. Actigraphy record

    Measured using Pendant Acceleration Data Logger

    Time frame: Total of 1 week between Visit 1 and 2

Secondary outcomes

  1. Light record

    Measured using Pendant Acceleration Data Logger

    Time frame: Total of 1 week between Visit 1 and 2

  2. Sleep record

    Measured using Pendant Acceleration Data Logger

    Time frame: Total of 1 week between Visit 1 and 2

Other outcomes

  1. Sleep Duration

    Sleep duration will be computed from self-reported

    Time frame: Total of 1 week between Visit 1 and 2

  2. Total Energy Intake

    Total energy intake in kcal/day will be computed from 7-day 24-hr dietary recalls

    Time frame: Total of 1 week between Visit 1 and 2

  3. Dietary Composition

    Macronutrient and micronutrient intake will be computed from 7-days of self-reported 24-hr dietary recalls

    Time frame: Total of 1 week between Visit 1 and 2

  4. Dietary Intake Timing

    Food timing will be self-reported and averaged across 7-days of 24-hr dietary recalls

    Time frame: Total of 1 week between Visit 1 and 2

  5. Chronotype

    Assessed using the Morningness-Eveningness Questionnaire

    Time frame: Total of 1 week between Visit 1 and 2

07

Study locations

1 site
  • Juan Ramón
    Murcia, 30100, Spain
08

References and documents

Publications

  • Lopez-Minguez J, Ordonana JR, Sanchez-Romera JF, Madrid JA, Garaulet M. Circadian system heritability as assessed by wrist temperature: a twin study. Chronobiol Int. 2015 Feb;32(1):71-80. doi: 10.3109/07420528.2014.955186. Epub 2014 Sep 10. PubMed 25208247 ↗
  • Lopez-Minguez J, Colodro-Conde L, Bandin C, Ordonana JR, Garaulet M, Madrid JA. Application of multiparametric procedures for assessing the heritability of circadian health. Chronobiol Int. 2016;33(2):234-44. doi: 10.3109/07420528.2015.1130051. Epub 2016 Jan 28. PubMed 26817403 ↗
  • Lopez-Minguez J, Dashti HS, Madrid-Valero JJ, Madrid JA, Saxena R, Scheer FAJL, Ordonana JR, Garaulet M. Heritability of the timing of food intake. Clin Nutr. 2019 Apr;38(2):767-773. doi: 10.1016/j.clnu.2018.03.002. Epub 2018 Mar 12. PubMed 29571565 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03059576
Lead sponsor
Universidad de Murcia
Responsible party
PROF. MARTA GARAULET AZA (Proffesor, Universidad de Murcia) — Principal investigator
First posted
Feb 23, 2017
Start date
Dec 2012
Primary completion
Mar 2013
Completion
Feb 2017
Last update
Mar 27, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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