- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059576
Circadian System Heritability Assessed in Free Living Conditions (MTR)
Circadian System Heritability Assessed in Free Living Conditions in a Twin Mediterranean Population
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Murcia, Spain, 30100
- Juan Ramón
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017ES00002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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