NCT02636335

Brief Summary

The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

December 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

December 14, 2015

Last Update Submit

June 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean power output in watts

    Power output during the first 30 minute time-trial on a bicycle ergometer.

Secondary Outcomes (3)

  • Subjective sleepiness

    1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial

  • Subjective Mood

    1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial

  • Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.

    Mean of the 30 minutes of the exercise from the first, second and third time-trial.

Study Arms (2)

Bright Light

EXPERIMENTAL

8 a.m. study participants will be exposed to Bright Light (4500 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer. The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart.

Device: Phillips Energy Light HF3319

Control

EXPERIMENTAL

8 a.m. study participants will be exposed to a Control Light Condition (230 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer. The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart.

Device: Phillips Energy Light HF3319

Interventions

Exposure to Light administered with Phillips Energy Light HF3319.

Bright LightControl

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index 25 - 35 kg/m2

You may not qualify if:

  • Women who are pregnant or breast feeding,
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Participation in other studies in the last four weeks
  • Systolic blood pressure \> 170 mmHg, diastolic blood pressure \> 100 mmHg
  • Shift work in the last two months
  • Travels across time zones in the last four weeks
  • Use of photosensitisation drugs
  • Clinical manifest depression
  • Cardiovascular diseases which reduce age-appropriate exercise capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Sport, Exercise and Health

Basel, 4052, Switzerland

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arno Schmidt-Trucksäss, Prof.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Departement of Sport, Exercise and Health, Principal Investigator

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 21, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06

Locations