NCT04302922

Brief Summary

Chronotype is defined as the midpoint of sleep and describes a biological construct of an organism's temporal organisation. Misalignment between the individual chronotype and socially determined schedules may result in a phenomenon called "social jetlag". Emerging evidence indicates that both, a later chronotype and/or a substantial "social jetlag" adversely affects metabolic health. Young adults may be particularly vulnerable to these exposures since the chronotype progressively delays from adolescence until early adulthood (approx. 20 years of age) before it advances again. Simultaneously, education in institutions or working hours starts early during the day, potentially contribute to substantial "social jetlag". Data on the development of overweight / obesity prevalence in Germany indicates that rates are now constant or declining in most adult age groups, with the clear exception of young adults, in whom rates continue to be on the rise. Nonetheless, the potential contribution of chronotype and/or social jetlag to this secular trend has not been addressed in Germany. Hence, the hypothesis of the ChroNu cohort is that individual chronotype and social jetlag are predictors of (changes in) the body composition in young adulthood (ages 18-25 years) and that changes in chronotype / social jetlag will result in changes in body composition. The ChroNu cohort forms part of the overall ChroNu study, which addresses the hypothesis that timing of food intake which diverges from the individual chronotype constitutes a characteristic of social jetlag which has adverse short- and long-term consequences for metabolic health (see The ChroNustudy). This study will recruit 300 healthy, non-obese students aged 18-25 years enrolled at Paderborn University until February 2020 and follow these up one year later. Chronotype and social jetlag will be determined using the validated MCTQ. Body composition will be assessed by bioimpedance analysis (BIA) The ChroNu cohort study will reveal important information on the relevance of a biologically determined phenomenon, i.e. the chronotype and the potentially resultant social jetlag for body composition development in a population vulnerable to increases in body fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration 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

September 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

January 22, 2020

Last Update Submit

April 2, 2024

Conditions

Keywords

Chronotypesocial jetlagbody compositionmeal timingtiming of physical activity

Outcome Measures

Primary Outcomes (1)

  • Change of body fat content from pre-post Covid-19 pandemic

    Body fat content \[kg\] is measured by bio-impedance analysis (BIA)

    Body fat will be measured both at baseline after enrolment and post-pandemic (follow up).

Secondary Outcomes (7)

  • Change in weight from pre-post Covid-19 pandemic

    Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.

  • Change in height from pre-post Covid-19 pandemic

    Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.

  • Change in BMI from pre-post Covid-19 pandemic

    Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.

  • Change in waist circumference from pre-post Covid-19 pandemic

    Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.

  • Change in daily routine and physical activity from pre-post Covid-19 pandemic

    The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

students of Paderborn University (see inclusion criteria)

You may qualify if:

  • Healthy students of Paderborn University
  • years old

You may not qualify if:

  • Students studying nutrition science
  • shift work in the past 3 months
  • crossing of \>1 time zone in the past 3 months
  • pregnancy
  • lactation
  • intake of medication such as antidepressants or sleeping pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paderborn University

Paderborn, North Rhine-Westphalia, 33098, Germany

Location

Study Officials

  • Anette E Buyken, Prof. Dr.

    Paderborn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Anette Buyken, Public Health Nutrition

Study Record Dates

First Submitted

January 22, 2020

First Posted

March 10, 2020

Study Start

September 1, 2019

Primary Completion

February 29, 2020

Study Completion

February 28, 2023

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations