Shift WorkNCT04182867
Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work.
A study testing Dietary intervention in people with Shift Work, run by King's College London at 1 site in United Kingdom.
Trial summary
The aim of this pilot study is to investigate the acute impact of diet quality modification during night work on 24-hr glucose variability (GV) and heart rate variability (HRV) in healthy free-living employees. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift Work
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2021to 30 Oct 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts.
- Body mass index between 18.5 and 35 kg/m2.
- Weight stable (no weight change by more than 3 kg in the last 2 months).
- Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study.
- Not pregnant or breastfeeding.
- Not diagnosed with heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.
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- Not currently taking medication to stabilize blood glucose (e.g. acarbose, metformin or sulfonylureas).
- Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
- Do not take medication for blood pressure e.g. diuretics, (beta-blockers, Ca-channel, ACE inhibitors, Angiotensin Receptor blockers)
- Do not have diagnosed hypertension (high blood pressure, systolic blood pressure that is higher than 180 mmHg and or diastolic blood pressure that is higher than 110 mmHg).
- Not diagnosed with arterial fibrillation or any other condition that affects heart rate (e.g. arrhythmia).
- No food intolerance, allergies, hypersensitivity or follow any dietary restrictions (e.g. gluten intolerance, coeliac, lactose intolerance, vegan or vegetarian) that will prevent the ability to follow the test diets.
- Do not have a history substance abuse, or current high alcohol intake (>28 units/week for males and >21 units/week for females).
- Able to understand the information sheet and willing to comply with study protocol and able to follow dietary instructions before and during the study.
- Ability to prepare basic meals from ingredients provided.
- No travel arrangements outside UK within the period of data collection.
- Not already participating in a clinical trial.
- Able to give informed written consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work: Shift-eat (Night) Pilot Study
The aim of this pilot study is to investigate the acute impact of diet quality modification during night work on 24-hr glucose variability (GV) and heart rate variability (HRV) in healthy free-living employees.
Read the detailed description
An increasing body of data reports deterioration of cardio-metabolic health in shift workers. For example, large scale meta-analyses have reported shift workers to be at increased risk of developing type 2 diabetes and of experiencing a coronary event, compared to day working employees.
Shift work causes complex changes in physiology (desynchrony of circadian rhythms) and behaviors including activity, sleep and eating patterns. The importance of meal timing is becoming increasingly recognized in both chronobiology and nutrition fields, with emerging awareness of 'chrono-nutrition', the interaction between nutrition and circadian time.
Given the importance to the economy of a healthy aging workforce, and the increase in shift work prevalence, it is important to establish if diet modification can reduce the health disparities between shift and day working employees.
- Conditions
- Shift Work
- Being tested
- Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Dietary modification (provision of diet).
| Study group | Role | What they receive |
|---|---|---|
| UK dietary guideline diet | Experimental | A 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). The experimental diet will meet UK dietary guidelines for fiber, salt, sugar, saturated fat, fruit and vegetable intake. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant. The diet will be consumed across 3 consecutive night shifts. Receives: Other: Dietary intervention |
| Shift worker diet | Other | A 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). Typical 'shift diet' based on previous research investigating what UK night workers eat. The 'shift diet' will contain ~15% energy from added sugar, 15g fiber, 2.5 portions fruit/vegetable, no whole grains. Required energy intake (calories) for each day to maintain their current body weight. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant.The diet will be consumed across 3 consecutive night shifts. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose variability (mean amplitude of glycaemic excursions)
24-hr blood glucose variability measured by continuous glucose monitor
Measured: 3 night shifts, an average of 72 hours
Blood glucose variability (coefficient variation)
24-hr blood glucose variability measured by continuous glucose monitor
Measured: 3 night shifts, an average of 72 hours
Blood glucose variability (time in range)
24-hr blood glucose variability measured by continuous glucose monitor
Measured: 3 night shifts, an average of 72 hours
Heart rate variability
24-hr heart rate variability measured by heart rate monitor
Measured: 3 night shifts, an average of 72 hours
Secondary outcomes (1)
Acceptability of test diet
Likert scale questionnaire
Measured: 3 night shifts, an average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start28 May 2021
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Why it stopped: Participant recruitment difficulties within the time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift WorkStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182867
- Sponsor's protocol ID
- Drum2019RG
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2019
- Last updated
- 14 Nov 2022
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work: Shift-eat (Night) Pilot Study
- ClinicalTrials.gov ID
- NCT04182867
- Acronym / sponsor ID
- Drum2019RG
- Conditions
- Shift Work
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant recruitment difficulties within the time frame
- Enrolment
- 4 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 2 Dec 2019 (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 pilot study is to investigate the acute impact of diet quality modification during night work on 24-hr glucose variability (GV) and heart rate variability (HRV) in healthy free-living employees.
Detailed description
An increasing body of data reports deterioration of cardio-metabolic health in shift workers. For example, large scale meta-analyses have reported shift workers to be at increased risk of developing type 2 diabetes and of experiencing a coronary event, compared to day working employees.
Shift work causes complex changes in physiology (desynchrony of circadian rhythms) and behaviors including activity, sleep and eating patterns. The importance of meal timing is becoming increasingly recognized in both chronobiology and nutrition fields, with emerging awareness of 'chrono-nutrition', the interaction between nutrition and circadian time.
Given the importance to the economy of a healthy aging workforce, and the increase in shift work prevalence, it is important to establish if diet modification can reduce the health disparities between shift and day working employees.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UK dietary guideline diet | Experimental | Other: Dietary interventionA 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). The experimental diet will meet UK dietary guidelines for fiber, salt, sugar, saturated fat, fruit and vegetable intake. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant. The diet will be consumed across 3 consecutive night shifts. |
| Shift worker diet | Other | Other: Dietary interventionA 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). Typical 'shift diet' based on previous research investigating what UK night workers eat. The 'shift diet' will contain ~15% energy from added sugar, 15g fiber, 2.5 portions fruit/vegetable, no whole grains. Required energy intake (calories) for each day to maintain their current body weight. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant.The diet will be consumed across 3 consecutive night shifts. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts.
- Body mass index between 18.5 and 35 kg/m2.
- Weight stable (no weight change by more than 3 kg in the last 2 months).
- Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study.
- Not pregnant or breastfeeding.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dietary interventionDietary modification (provision of diet). | Other | Shift worker diet, UK dietary guideline diet |
Primary outcome
Blood glucose variability (mean amplitude of glycaemic excursions)
Time frame: 3 night shifts, an average of 72 hours
24-hr blood glucose variability measured by continuous glucose monitor
Blood glucose variability (coefficient variation)
Time frame: 3 night shifts, an average of 72 hours
24-hr blood glucose variability measured by continuous glucose monitor
Blood glucose variability (time in range)
Time frame: 3 night shifts, an average of 72 hours
24-hr blood glucose variability measured by continuous glucose monitor
Heart rate variability
Time frame: 3 night shifts, an average of 72 hours
24-hr heart rate variability measured by heart rate monitor
1 secondary outcome
Acceptability of test diet
Time frame: 3 night shifts, an average of 72 hours
Results and safety
The study was stopped early (reason given: Participant recruitment difficulties within the time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Shift Work, run by King's College London 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 18 inclusion and 0 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: stopped early, as of the sponsor's last update on 14 Nov 2022. 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 was stopped early (reason given: Participant recruitment difficulties within the time frame). Results are not available in the source record.
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?
Blood glucose variability (mean amplitude of glycaemic excursions) (time frame: 3 night shifts, an average of 72 hours). The study lists 4 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 14 Nov 2022.