Clinical trial NCT03059576: Circadian System Heritability Assessed in Free Living Conditions
Official title: Circadian System Heritability Assessed in Free Living Conditions in a Twin Mediterranean Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Chronobiology
Circadian rhythms
Heritability
Twins
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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.

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).

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

Primary outcomes:
measure: Temperature record
timeFrame: Total of 1 week between Visit 1 and 2
measure: Actigraphy record
timeFrame: Total of 1 week between Visit 1 and 2
Secondary outcomes:
measure: Light record
timeFrame: Total of 1 week between Visit 1 and 2
measure: Sleep record
timeFrame: Total of 1 week between Visit 1 and 2
Other outcomes:
measure: Sleep Duration
timeFrame: Total of 1 week between Visit 1 and 2
measure: Total Energy Intake
timeFrame: Total of 1 week between Visit 1 and 2
measure: Dietary Composition
timeFrame: Total of 1 week between Visit 1 and 2
measure: Dietary Intake Timing
timeFrame: Total of 1 week between Visit 1 and 2
measure: Chronotype
timeFrame: Total of 1 week between Visit 1 and 2
Locations:
city: Murcia
country: Spain
facility: Juan Ramón
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.