FIT 2 SIT - Are Metabolic Responses to Sitting/Light Breaks Mediated by Fitness?

NCT ID: NCT02493309

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether an individuals cardio-respiratory fitness level can protect them from the negative metabolic impacts of prolonged sitting time.

Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will not be as substantial, nor will light activity breaks be as advantageous, compared to individuals with lower fitness as they have a smaller scope for metabolic improvement.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The FIT 2 SIT study requires three separate study visits in total.

At visit one, we will check the participants blood pressure, height, weight, waist measurement and body fat percentage, we will also take a blood sample to measure HbA1c and cholesterol, all of which will help confirm that this participant is eligible to continue in this study (some may be excluded based on results of the above). We will also measure the amount of energy participants expend per minute while at rest and during a slow walking task (3km.h on a treadmill) using a gas mask technique. Energy responses to sitting and walking differ between individuals, therefore it is of interest to observe how each participant in this study responds to these conditions as it may help explain any potential findings of this study. For instance, introducing walking breaks (by way of reducing sitting time) may only benefit those who have consequent increases in energy expenditure as a result of these breaks. Lastly, to mark the end of the first study visit, participants will be asked to perform an exercise test based on a treadmill to assess their fitness level. whilst running a special mask covering the nose and mouth will be worn to analyse breathing, this will be connected to a machine (gas analyser) that gives information on the amount of oxygen participants breathe in and out. The point at which the amount of oxygen they breathe in remains stable despite increases in exercise difficulty is the point that we will stop the exercise test because this tells us that they have reached their exercise capacity (called V02max), and from this we can determine fitness level.

Following this first visit we will have fitness level data from all participants. Recruiting participants with a diverse fitness level will then help to elucidate the role that an individuals fitness has on their response to the following treatment conditions.

Treatment condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm) whilst watching TV/DVD's, reading, using the internet, doing paperwork etc. at their will. On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day, without the need for multiple needles. After we take the first blood sample, participants will sit quietly for an hour. We will then provide breakfast. Whilst sitting, we will take blood samples (using the cannula) and blood pressure at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period. Although this may sound a lot, it is equivalent to around 8-9 teaspoons of blood over the course of the day.

Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.

With data on each participants metabolic response to a meal during A) prolonged sitting and B) during an interrupted sitting condition, we can see how fitness influenced the results.

However, at present, the absence of laboratory randomised crossover trials assessing the 'extent' to which fitness moderates the relationship between sedentary behaviour and metabolic health markers appear absent from the literature, warranting further investigation, which is why this design was chosen.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prolonged sitting

Group Type EXPERIMENTAL

Prolonged sitting

Intervention Type OTHER

Condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period.

Light activity breaks

Group Type ACTIVE_COMPARATOR

Light activity breaks

Intervention Type OTHER

Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prolonged sitting

Condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period.

Intervention Type OTHER

Light activity breaks

Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study
* Body Mass Index: 20 - 30 kg/m2
* Male and Female
* Aged: ≥ 25 to ≤ 55 years of age.
* Occupation: Work full-time in a predominantly sedentary occupation.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

* Aged \<25 or \>55 years of age.
* Physical condition which limits full participation in the study
* Active psychotic illness or other significant illness which, in the view of the investigators, would prevent full participation
* Inability to communicate in spoken English
* Steroid use
* Known Type 2 Diabetes
* Pre-existing Cardio-vascular Disease (disease of the heart or blood vessels at present or in the past) For example: Heart attack, Stroke or Angina.
* Pregnancy
* Smoker
* Terminal illness
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Leicester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Yates, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leicester Diabetes Centre, Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ll.dlpa.bru.nihr.ac.uk/

NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRN151741

Identifier Type: OTHER

Identifier Source: secondary_id

0458

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Training Effects on Fuel Metabolism
NCT02150889 ACTIVE_NOT_RECRUITING NA