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Completed

NCT Number: NCT03059576

Circadian System Heritability Assessed in Free Living Conditions

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Juan Ramón

Murcia, 30100, Spain

About this study

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).

Who can participate

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

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

Treatment and study plan

Chronobiological status of the subjects

Other

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.

Primary outcomes

  1. Temperature record

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

    Measured using temperature sensor

  2. Actigraphy record

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

    Measured using Pendant Acceleration Data Logger

Secondary outcomes

  1. Light record

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

    Measured using Pendant Acceleration Data Logger

  2. Sleep record

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

    Measured using Pendant Acceleration Data Logger

Other outcomes

  1. Sleep Duration

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

    Sleep duration will be computed from self-reported

  2. Total Energy Intake

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

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

  3. Dietary Composition

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

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

  4. Dietary Intake Timing

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

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

  5. Chronotype

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

    Assessed using the Morningness-Eveningness Questionnaire

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Circadian System Heritability Assessed in Free Living Conditions in a Twin Mediterranean Population

Acronym: MTR

Important dates

Study start
2012
Primary completion
2013
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Mar 27, 2017

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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