Circadian System Heritability Assessed in Free Living Conditions

Healthy Clinical Trial

— MTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059576
• Other study ID #: 2017ES00002
• Status: Completed
• Phase: N/A
• First received: February 13, 2017
• Last updated: March 23, 2017
• Start date: December 2012
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2017
• Est. primary completion date: March 2013
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Chronobiological 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.

Locations

Country	Name	City	State
Spain	Juan Ramón	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Lopez-Minguez J, Colodro-Conde L, Bandín C, Ordoñana 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. — View Citation

Lopez-Minguez J, Ordoñana JR, Sánchez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Duration	Sleep duration will be computed from self-reported	Total of 1 week between Visit 1 and 2
Other	Total Energy Intake	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
Other	Dietary Composition	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
Other	Dietary Intake Timing	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
Other	Chronotype	Assessed using the Morningness-Eveningness Questionnaire	Total of 1 week between Visit 1 and 2
Primary	Temperature record	Measured using temperature sensor	Total of 1 week between Visit 1 and 2
Primary	Actigraphy record	Measured using Pendant Acceleration Data Logger	Total of 1 week between Visit 1 and 2
Secondary	Light record	Measured using Pendant Acceleration Data Logger	Total of 1 week between Visit 1 and 2
Secondary	Sleep record	Measured using Pendant Acceleration Data Logger	Total of 1 week between Visit 1 and 2