Circadian System Heritability Assessed in Free Living Conditions (MTR)

March 23, 2017 updated by: PROF. MARTA GARAULET AZA, Universidad de Murcia

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Murcia, Spain, 30100
        • Juan Ramón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature record
Time Frame: Total of 1 week between Visit 1 and 2
Measured using temperature sensor
Total of 1 week between Visit 1 and 2
Actigraphy record
Time Frame: Total of 1 week between Visit 1 and 2
Measured using Pendant Acceleration Data Logger
Total of 1 week between Visit 1 and 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light record
Time Frame: Total of 1 week between Visit 1 and 2
Measured using Pendant Acceleration Data Logger
Total of 1 week between Visit 1 and 2
Sleep record
Time Frame: Total of 1 week between Visit 1 and 2
Measured using Pendant Acceleration Data Logger
Total of 1 week between Visit 1 and 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Duration
Time Frame: Total of 1 week between Visit 1 and 2
Sleep duration will be computed from self-reported
Total of 1 week between Visit 1 and 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
Total of 1 week between Visit 1 and 2
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
Total of 1 week between Visit 1 and 2
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
Total of 1 week between Visit 1 and 2
Chronotype
Time Frame: Total of 1 week between Visit 1 and 2
Assessed using the Morningness-Eveningness Questionnaire
Total of 1 week between Visit 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2017ES00002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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