MTR: Circadian System Heritability Assessed in Free Living Conditions

Sponsor

Universidad de Murcia (Other)

Overall Status

Completed

CT.gov ID

NCT03059576

Collaborator

(none)

106

Enrollment

Location

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Chronobiological status of the subjects

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 Design

Study Type:

Observational

Actual Enrollment :

106 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Feb 1, 2017

Outcome Measures

Primary Outcome Measures

Temperature record [Total of 1 week between Visit 1 and 2]
Measured using temperature sensor
Actigraphy record [Total of 1 week between Visit 1 and 2]
Measured using Pendant Acceleration Data Logger

Secondary Outcome Measures

Light record [Total of 1 week between Visit 1 and 2]
Measured using Pendant Acceleration Data Logger
Sleep record [Total of 1 week between Visit 1 and 2]
Measured using Pendant Acceleration Data Logger

Other Outcome Measures

Sleep Duration [Total of 1 week between Visit 1 and 2]
Sleep duration will be computed from self-reported
Total Energy Intake [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
Dietary Composition [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
Dietary Intake Timing [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
Chronotype [Total of 1 week between Visit 1 and 2]
Assessed using the Morningness-Eveningness Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juan Ramón	Murcia		Spain	30100

Sponsors and Collaborators

Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

PROF. MARTA GARAULET AZA, Proffesor, Universidad de Murcia

ClinicalTrials.gov Identifier:

NCT03059576

Other Study ID Numbers:

2017ES00002

First Posted:

Feb 23, 2017

Last Update Posted:

Mar 27, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by PROF. MARTA GARAULET AZA, Proffesor, Universidad de Murcia

Study Results

No Results Posted as of Mar 27, 2017