TerminatedNot Applicable

Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work.

Stopped: Participant recruitment difficulties within the time frame

United Kingdom4 participantsStarted 2021-05-28

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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 vegetari…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood glucose variability (mean amplitude of glycaemic excursions)

Timeframe: 3 night shifts, an average of 72 hours

Blood glucose variability (coefficient variation)

Timeframe: 3 night shifts, an average of 72 hours

Blood glucose variability (time in range)

Timeframe: 3 night shifts, an average of 72 hours

Heart rate variability

Timeframe: 3 night shifts, an average of 72 hours

Trial details

NCT IDNCT04182867

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Shift Work trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Blood glucose variability (mean amplitude of glycaemic excursions)

Timeframe: 3 night shifts, an average of 72 hours

Blood glucose variability (coefficient variation)

Timeframe: 3 night shifts, an average of 72 hours

Blood glucose variability (time in range)

Timeframe: 3 night shifts, an average of 72 hours

Heart rate variability

Timeframe: 3 night shifts, an average of 72 hours