HealthyMTRNCT03059576
Circadian System Heritability Assessed in Free Living Conditions
An observational study of Healthy, run by Universidad de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Chronobiological status of the subjects
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Chronobiological status of the subjects
- Keywords
- Chronobiology, Circadian rhythms, Heritability, Twins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronobiological status of the subjectsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature record
Measured using temperature sensor
Measured: Total of 1 week between Visit 1 and 2
Actigraphy record
Measured using Pendant Acceleration Data Logger
Measured: Total of 1 week between Visit 1 and 2
Secondary outcomes (2)
Light record
Measured using Pendant Acceleration Data Logger
Measured: Total of 1 week between Visit 1 and 2
Sleep record
Measured using Pendant Acceleration Data Logger
Measured: Total of 1 week between Visit 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startDec 2012
- Primary completionMar 2013
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PROF. MARTA GARAULET AZA, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059576
- Sponsor's protocol ID
- 2017ES00002
- Acronym
- MTR
- Status last verified
- Mar 2017
- First submitted
- 13 Feb 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25208247Lopez-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.
PubMed 26817403Lopez-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.
PubMed 29571565
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian System Heritability Assessed in Free Living Conditions in a Twin Mediterranean Population
- ClinicalTrials.gov ID
- NCT03059576
- Acronym / sponsor ID
- MTR / 2017ES00002
- Conditions
- Healthy
- Keywords
- Chronobiology, Circadian rhythms, Heritability, Twins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronobiological status of the subjectsParticipation 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. | Other | – |
Primary outcome
Temperature record
Time frame: Total of 1 week between Visit 1 and 2
Measured using temperature sensor
Actigraphy record
Time frame: Total of 1 week between Visit 1 and 2
Measured using Pendant Acceleration Data Logger
2 secondary outcomes
Light record
Time frame: Total of 1 week between Visit 1 and 2
Sleep record
Time frame: Total of 1 week between Visit 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Background: PubMed 25208247Lopez-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.
- Background: PubMed 26817403Lopez-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.
- Derived from this study: PubMed 29571565Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature record (time frame: Total of 1 week between Visit 1 and 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059576, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.