Metabolic DiseaseNCT06240663
Walking Before or After Breakfast - Which is Better to Improve Health in Overweight Individuals?
A study testing Exercise in people with Metabolic Disease and Insulin Resistance, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the effectiveness of a home-based walking-based exercise intervention undertaken in the fed or fasted state to improve glycaemic control in overweight and obese individuals. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metabolic Disease, Insulin Resistance
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2020to 30 Apr 2021
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20-60 years
- BMI >28 kg.m-2
- Not currently using any anti-diabetes medication
- Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
- Not pregnant or currently breast feeding
- Pre-menopausal or peri-menopausal
- Not currently involved in a weight loss programme or using weight loss medication
Who cannot join
- Involved in regular exercise (engaged in more than 3 sessions of structured exercise of >30 min per week)
- Currently using anti-diabetes medication (e.g. insulin, metformin)
- Pregnant or breast feeding
- Currently engaged in active weight loss programme or using weight loss medication
- Diagnosed with chronic kidney disease
- Post-menopausal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
Official title: A Free-living, Walking-based, Exercise Programme, With Exercise Timed Relative to Breakfast, to Improve Metabolic Health in People Living With Obesity: A Feasibility Study
The aim of this study is to investigate the effectiveness of a home-based walking-based exercise intervention undertaken in the fed or fasted state to improve glycaemic control in overweight and obese individuals. This study will evaluate the adherence and compliance to this "real-world" exercise programme that requires no face-to-face contact with the research team. It is also hypothesised that individuals who exercise before breakfast (fasted) will see greater improvements in glycaemic control than those who exercise after breakfast.
Read the detailed description
Individuals with a BMI above 28 will be recruited to investigate whether a home-based walking exercise intervention in the fasted or fed state is feasible to implement into real-world situation. Secondary to that, this study will investigate whether a fasted or fed intervention more effective for improving metabolic health. To do this, individuals will provide written consent, and then carry out baseline measures in their own home:
Waist-to-hip ratio and weight: Participants will be provided with a tape measure to measure waist circumference and hip circumference. From this, waist-to-hip ratio will be calculated. Additionally, participants will be asked to use their own scales to provide their weight (if they don't have any they will be provided).
CGM: Participants will receive a continuous blood glucose monitor and be directed over teams how to fit this. One will be worn for two weeks in weeks 0 and 1 and another will be worn for two weeks in weeks 12 and 13.
Diet: Participants will receive a food diary to record their habitual dietary intake for three days (24 hours after the CGM is fitted). During the first week on the intervention they will also be asked to write down what they eat for lunch on the days they exercise.
Fitness test: Participants will receive a polar beat heart rate monitor. They will be asked to complete tthe harvard step test wearing the HR monitor at least 48 hours before they begin the intervention.
Exercise intervention:
Pairs of participants from each group (matched for gender, age, BMI and) will be randomized to undertake 12 weeks of steady walking in either a fasted state (before breakfast each day) or a fed state (after breakfast each day). They will be asked to eat the same breakfast on each day they complete the exercise, whether it is before or after.
Walking sessions will be 4 times per week and will be two continuous sessions (~50% HR max) and two interval sessions (3 minutes at 40% HR max, 3 minutes 80% HR max) monitored by the polar beat app. Participants will initially walk for 30 minute sessions in week 1 and this will increase by 5 minutes each week until they are completing 4x 60 minute sessions per week (see table.1).
A CGM will be in place during week 1 to measure the glycaemic response to exercise. And a second CGM will be inserted at the beginning of week 12 to see the changes in glycaemic control on exercise days and will remain in place for post-intervention CGM monitoring.
- Conditions
- Metabolic Disease, Insulin Resistance
- Being tested
- Exercise
- Medical subject headings
- Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Both groups complete the exercise intervention identically, but one is in the fasted state and one is in the fed state.
| Study group | Role | What they receive |
|---|---|---|
| Fasted | Experimental | Half the participants completed this exercise intervention in the fasted state. Receives: Behavioral: Exercise |
| Fed | Experimental | Half the participants completed this exercise intervention in the fed state. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhearance
Do individuals complete all the exercise sessions.
Measured: Number of exercise sessions are counted. There are 4 exercise sessions prescribed per week for 12 weeks.
Compliance
Do participants complete each exercise session as prescribed?
Measured: HR and duration are measured during every exercise session to calculate this. There are 4 exercise sessions prescribed per week for 12 weeks.
Secondary outcomes (5)
HbA1c
A Thriva blood sample kit is sent to individuals through the post. t in the post to measure HbA1c, key liver enzymes and cholesterol markers.
Measured: 0 and 12 weeks.
Waist circumference
Participants are sent a tape measure in the post and asked to measure the smallest part of their waist.
Measured: 0 and 12 weeks.
Time in Range for Plasma Glucose
Measured using continuous glucose monitoring
Measured: Days 0 - 14 and days 77 - 91
Alanine Transferase
A Thriva blood sample kit is sent to individuals through the post.
Measured: 0 and 12-weeks.
Hip Circumference
Participants are sent a tape measure in the post and asked to measure the biggest part of their hip.
Measured: 0 and 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 May 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Responsible party
- Sponsor
- Investigators
- Sam O Shepherd, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240663
- Sponsor's protocol ID
- 20/SPS021
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Free-living, Walking-based, Exercise Programme, With Exercise Timed Relative to Breakfast, to Improve Metabolic Health in People Living With Obesity: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06240663
- Acronym / sponsor ID
- 20/SPS021
- Conditions
- Metabolic Disease, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 Feb 2024 (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 aim of this study is to investigate the effectiveness of a home-based walking-based exercise intervention undertaken in the fed or fasted state to improve glycaemic control in overweight and obese individuals. This study will evaluate the adherence and compliance to this "real-world" exercise programme that requires no face-to-face contact with the research team. It is also hypothesised that individuals who exercise before breakfast (fasted) will see greater improvements in glycaemic control than those who exercise after breakfast.
Detailed description
Individuals with a BMI above 28 will be recruited to investigate whether a home-based walking exercise intervention in the fasted or fed state is feasible to implement into real-world situation. Secondary to that, this study will investigate whether a fasted or fed intervention more effective for improving metabolic health. To do this, individuals will provide written consent, and then carry out baseline measures in their own home:
Waist-to-hip ratio and weight: Participants will be provided with a tape measure to measure waist circumference and hip circumference. From this, waist-to-hip ratio will be calculated. Additionally, participants will be asked to use their own scales to provide their weight (if they don't have any they will be provided).
CGM: Participants will receive a continuous blood glucose monitor and be directed over teams how to fit this. One will be worn for two weeks in weeks 0 and 1 and another will be worn for two weeks in weeks 12 and 13.
Diet: Participants will receive a food diary to record their habitual dietary intake for three days (24 hours after the CGM is fitted). During the first week on the intervention they will also be asked to write down what they eat for lunch on the days they exercise.
Fitness test: Participants will receive a polar beat heart rate monitor. They will be asked to complete tthe harvard step test wearing the HR monitor at least 48 hours before they begin the intervention.
Exercise intervention:
Pairs of participants from each group (matched for gender, age, BMI and) will be randomized to undertake 12 weeks of steady walking in either a fasted state (before breakfast each day) or a fed state (after breakfast each day). They will be asked to eat the same breakfast on each day they complete the exercise, whether it is before or after.
Walking sessions will be 4 times per week and will be two continuous sessions (~50% HR max) and two interval sessions (3 minutes at 40% HR max, 3 minutes 80% HR max) monitored by the polar beat app. Participants will initially walk for 30 minute sessions in week 1 and this will increase by 5 minutes each week until they are completing 4x 60 minute sessions per week (see table.1).
A CGM will be in place during week 1 to measure the glycaemic response to exercise. And a second CGM will be inserted at the beginning of week 12 to see the changes in glycaemic control on exercise days and will remain in place for post-intervention CGM monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted | Experimental | Behavioral: ExerciseHalf the participants completed this exercise intervention in the fasted state. |
| Fed | Experimental | Behavioral: ExerciseHalf the participants completed this exercise intervention in the fed state. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 20-60 years
- BMI >28 kg.m-2
- Not currently using any anti-diabetes medication
- Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
- Not pregnant or currently breast feeding
Key exclusion criteria (6 listed)
- Involved in regular exercise (engaged in more than 3 sessions of structured exercise of >30 min per week)
- Currently using anti-diabetes medication (e.g. insulin, metformin)
- Pregnant or breast feeding
- Currently engaged in active weight loss programme or using weight loss medication
- Diagnosed with chronic kidney disease
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 |
|---|---|---|
| ExerciseBoth groups complete the exercise intervention identically, but one is in the fasted state and one is in the fed state. | Behavioural | Fasted, Fed |
Primary outcome
Adhearance
Time frame: Number of exercise sessions are counted. There are 4 exercise sessions prescribed per week for 12 weeks.
Do individuals complete all the exercise sessions.
Compliance
Time frame: HR and duration are measured during every exercise session to calculate this. There are 4 exercise sessions prescribed per week for 12 weeks.
Do participants complete each exercise session as prescribed?
5 secondary outcomes
HbA1c
Time frame: 0 and 12 weeks.
Waist circumference
Time frame: 0 and 12 weeks.
Time in Range for Plasma Glucose
Time frame: Days 0 - 14 and days 77 - 91
Alanine Transferase
Time frame: 0 and 12-weeks.
Hip Circumference
Time frame: 0 and 12-weeks.
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 5 Feb 2024.
- 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.
Sam O Shepherd, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Metabolic Disease and Insulin Resistance, run by Liverpool John Moores University at 1 site in United Kingdom.
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 7 inclusion and 6 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 5 Feb 2024. 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 United Kingdom. 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?
Adhearance (time frame: Number of exercise sessions are counted. There are 4 exercise sessions prescribed per week for 12 weeks.). 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?
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 5 Feb 2024.