NCT03059576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

February 13, 2017

Last Update Submit

March 23, 2017

Conditions

Healthy

Keywords

ChronobiologyCircadian rhythmsHeritabilityTwins

Outcome Measures

Primary Outcomes (2)

  • Temperature record

    Measured using temperature sensor

    Total of 1 week between Visit 1 and 2

  • Actigraphy record

    Measured using Pendant Acceleration Data Logger

    Total of 1 week between Visit 1 and 2

Secondary Outcomes (2)

  • Light record

    Total of 1 week between Visit 1 and 2

  • Sleep record

    Total of 1 week between Visit 1 and 2

Other Outcomes (5)

  • Sleep Duration

    Total of 1 week between Visit 1 and 2

  • Total Energy Intake

    Total of 1 week between Visit 1 and 2

  • Dietary Composition

    Total of 1 week between Visit 1 and 2

  • +2 more other outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Body Mass Index: \>19 kg/m2
  • Age: between 18 and 70 year of age
  • Caucasian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Ramón

Murcia, Murcia, 30100, Spain

Location

Related Publications (3)

  • 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.

    PMID: 25208247BACKGROUND

  • 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.

    PMID: 26817403BACKGROUND

  • 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.

    PMID: 29571565DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

February 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)