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Trial registered on ANZCTR

Registration number

ACTRN12617000791336

Ethics application status

Approved

Date submitted

23/05/2017

Date registered

30/05/2017

Date last updated

3/12/2020

Date data sharing statement initially provided

3/12/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Shifting the Risk Study (Investigating meal timing and heart health in shift workers)

Scientific title

Does modifying the timing of meal intake improve cardiovascular risk factors: A pilot intervention in shift workers with abdominal obesity.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular disease

Diabetes

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

Diabetes

Inflammatory and Immune System

Normal development and function of the immune system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

PROCEDURES
Participants will be randomised to begin with the Intervention period or the Control period. There will be a minimum of two week washout between the two periods.

Intervention period (manipulation of meal times)

Participants will be asked to avoid food intake for a five hour period during the night, for a continuous four week period (minimum 28 days). They will receive a face-to-face individual meeting with a dietitian, who will provide them with a tailored eating plan, to redistribute the timing of food intake. During the four week Intervention period, participants will also be asked to:
- Complete one 24-hour food recall each week (four in total).
- Wear a Sensewear activity monitor for 5 days. The Sensewear activity monitors are used to collect physical activity information.

During the study period, participants will also be asked to collect urine for a continuous 48-hour period (maximum of two occasions). This is used to analyse the concentration of aMT6s, which is the primary urinary metabolite of melatonin.

In order to measure metabolic outcomes, participants will be asked to partake in acute meal challenges: once at baseline and once after the Intervention period.

Each acute meal challenge will run for approximately 7 hours (~8am – 2:30pm). After a 10-hour fast, participants will arrive at the Be Active Sleep and Eat (BASE) facility at 8am. Anthropometric (weight, waist circumference) and body composition measures will be taken. A trained nurse or phlebotomist will then insert a cannula in the participant’s forearm and a baseline blood sample will be taken. Participants will be provided with a high fat breakfast meal (~45% energy from fat), to be consumed within 15 minutes. Blood samples will be taken for a total of 6 hours post-meal (timing begins at commencement of meal intake): at 15, 30, 45, 60, 90, 120 minutes and then hourly for the next 4 hours. The maximum amount of blood that will be collected during this 6-hour period is 120ml. Participants will be permitted water (but no other food or drinks) and are to remain sedentary during this period. Participants will also be asked to complete surveys regarding their shift schedule, sleep, exercise habits and general well-being during this period.

WHO WILL DELIVER THE INTERVENTION:
Participants’ progress through the entire study will be monitored by two PhD students from the Department of Nutrition, Dietetics and Food of Monash University, Australia. The dietetic consult will be performed by an Accredited Practising Dietitian. Trained nurses or phlebotomists will perform cannulation and blood draws during the acute meal challenges.

MODE OF DELIVERY
The intervention of the study is avoiding food intake at night for a specified period. Participants will receive an initial face-to-face individual meeting with a dietitian, who will help them reorganise their usual meal pattern to avoid food intake between the specified hours. As the participants will be asked to maintain the types and amount of food they usually eat, changing only the timing of food intake, regular follow-up with the dietitian will not be necessary. However, they are encouraged to contact the dietitian or other research team members by phone or email if they have difficulties maintaining this intervention.

LOCATION
The participants will be free-living. The acute meal challenges will be conducted in the Be Active Sleep and Eat (BASE) Research Facility at Monash University (Notting Hill, Victoria, Australia).

DURATION AND TIME FRAME
The entire study will be approximately 13 weeks in duration. Participants will be in the Intervention period for a continuous 4 weeks (28 days minimum). The acute meal challenges will be conducted once at baseline and once after the Intervention period. Each of acute meal challenges will be approximately 7 hours in duration. Participants will meet with the dietitian during the acute meal challenge prior to the commencement of Intervention period, this will take 30 minutes to an hour.

TAILORING
Individually tailored meal plans will be provided, in regards to the redistribution of food intake to other times of the day to avoid the specified period during the night. Participants’ food preferences and usual meal times will vary; dietary advice will be based on these.

MAINTAINING ADHERENCE
During the Intervention Period, participants will be sent automated text messages on every night shift, to remind them not to eat at night. 24-hour food recalls will be completed once a week during the Intervention period to help monitor compliance. Participants will be contacted via phone on their first day off after a continuous row of night shifts and be asked to recall their intake of the day prior.

Intervention code [1]

Lifestyle

Comparator / control treatment

PROCEDURE
Control period (ad-libitum eating)
Participants will be asked to maintain/return to their habitual dietary intake for a continuous four week period (minimum 28 days). During the four week Control period, participants will also be asked to:
- Complete one 24-hour food recall each week (four in total).
- Wear a Sensewear activity monitor for 5 days. The Sensewear activity monitors are used to collect physical activity information.

Participants will partake in another acute meal challenge after the Control Period (i.e.: total of three in entire study). The procedure of the acute meal challenge is described in the Intervention section above.

LOCATION
The participants will be free-living. The acute meal challenges will be conducted in the Be Active Sleep and Eat (BASE) Research Facility at Monash University (Notting Hill, Victoria, Australia).

DURATION AND TIME FRAME
Participants will be in Control period for a continuous 4 weeks (28 days minimum). The acute meal challenge will be conducted once after the Control period and it will take approximately 7 hours.

MAINTAINING ADHERENCE
24-hour food recalls will be completed once a week during the Control period to help monitor compliance. Participants will be contacted via phone on their first day off after a continuous row of night shifts and be asked to recall their intake of the day prior.

Control group

Active

Outcomes

Primary outcome [1]

Lipid concentration as assessed during acute meal challenges. Serum lipid concentration will be analysed using the Indiko Clinical and Speciality Chemistry System.

Timepoint [1]

Lipid concentration will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for lipids will be taken at baseline, then at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 minutes post-meal.

Primary outcome [2]

Glucose concentration as assessed during acute meal challenges. Plasma glucose concentration will be analysed using the Indiko Clinical and Speciality Chemistry System.

Timepoint [2]

Glucose concentration will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for glucose will be taken at baseline, then at 15, 30, 45, 60, 90, 120 and 180 minutes post-meal.

Secondary outcome [1]

Insulin concentration as assessed during acute meal challenges. Plasma insulin concentration will be analysed using commercial immunoassay kits.

Timepoint [1]

Insulin concentration will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for insulin will be taken at baseline, then at 15, 30, 45, 60, 90, 120 and 180 minutes post-meal.

Secondary outcome [2]

Fasting endothelial function blood markers, analysed using commercial ELISA kits.

Timepoint [2]

Fasting concentration of endothelial function blood markers will be measured:
1) after the 4 week Intervention and
2) after the 4 week Control period.

Secondary outcome [3]

A composite of inflammatory cytokines (e.g.: TNF-alpha, IL-8 and other novel markers), as assessed during the acute meal challenge. Plasma/serum inflammatory cytokines concentration will be analysed using the Magpix Clinical Diagnostics Instrument.

Timepoint [3]

Inflammatory cytokines concentrations will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for inflammatory cytokines will be taken at baseline, then at 1, 2, 4 and 6 hours post-meal.

Eligibility

Key inclusion criteria

Night shift workers (working at least 4 night shifts per fortnight) with abdominal obesity.

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Day time workers
- Have been working night shift for less than one consecutive year
- Working less than 4 night shifts per fortnight on average
- Waist circumference below 80 cm (all females), below 94 cm (Non-Asian males) or below 90 cm (Asian males)
- Diagnosed with diabetes, high blood lipids or cardiovascular disease
- Taking medication for diabetes, high blood pressure, high blood lipids, cardiovascular disease or those known to alter body composition or metabolism (e.g.: thyroxin, insulin sensitisers, glucocorticoids or anti-depressants).
- Pregnant, planning a pregnancy or breastfeeding
- Those who consume 4 or more standard drinks on one occasion, at a "daily or almost daily" occurrence

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The allocation sequence will be generated by a researcher who is not involved in determining participant eligibility. The allocation sequence will be kept in a password-protected computer file; which the researchers involved in screening the participants will not be able to access.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation (with random block sizes) using a computerised sequence generator will determine the order in which the participants receive the intervention. Block sizes will be kept confidential to the researchers randomising participants to the order of intervention.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

n/a

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size:
In the absence of literature with study design and endpoints similar to that proposed in this study, a power calculation could not be conducted. The current study serves as a pilot study, to determine the required sample size to achieve study objectives. We aim to have 20 participants complete the study. Accounting for a 30% attrition rate, we will aim to recruit 28 participants.

Analysis plan:
Primary outcomes (postprandial lipids and glucose) will be compared between two periods: post-Intervention and post-Control period. This will be conducted using the CROS analysis method (1), which takes into account period effects. Briefly, CROS analysis (1) will involve an analysis of variance (ANOVA) with lipid and glucose concentration at the end of each period as the outcome variables and patient, period and intervention group as the factor variables. Similar methods will be used to assess the difference between the two interventions for secondary outcomes. In cases where the baseline levels of an outcome are deemed important confounders, analysis of co-variance (ANCOVA) will be used. For instances where assumptions of ANOVA are not met, a non-parametric equivalent test will be used.

Reference:
1. Jones B, Kenward MG. Design and Analysis of CrossOver Trials. 2nd ed. London: Chapman and Hall, 2003.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/08/2017

Actual

24/08/2017

Date of last participant enrolment

Anticipated

30/06/2018

Actual

11/07/2018

Date of last data collection

Anticipated

1/12/2018

Actual

11/10/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Heart Foundation (Vanguard grant)

Address [1]

Level 12/500 Collins Street, Melbourne, VIC 3000.

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Maxine Bonham

Address

Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Catherine Huggins

Address [1]

Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash Research Office, 26 Sports Walk, Monash University, Wellington Road, Clayton VIC  3800.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/05/2017

Approval date [1]

17/05/2017

Ethics approval number [1]

8619

Summary

Brief summary

Shift workers face a 40% higher risk of heart disease and type-2 diabetes compared to day workers. Night shift workers are likely to change their sleeping and eating patterns to suit their work schedule. Therefore, the purpose of this study is to look at the effects of changing meal times at night on the heart health of shift workers. Briefly, the study involves two periods: 1) where participants are asked to avoid eating during a specified time period of the night and 2) where participants are asked to maintain their usual eating habits. We will then test to see the difference in participants’ blood fats, sugars, and other cardiovascular risk markers between these two periods.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Maxine Bonham

Address

Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.

Country

Australia

Phone

(+61) 3 9902 4272

Fax

[email protected]

Contact person for public queries

Name

Maxine Bonham

Address

Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.

Country

Australia

Phone

(+61) 3 9902 4199

Fax

[email protected]

Contact person for scientific queries

Name

Maxine Bonham

Address

Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.

Country

Australia

Phone

(+61) 3 9902 4272

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9958	Study protocol	Bonham MP, Leung GKW, Davis R, et al. Does modifying the timing of meal intake improve cardiovascular risk factors? Protocol of an Australian pilot intervention in night shift workers with abdominal obesity. BMJ Open 2018;8:e020396. doi: 10.1136/bmjopen-2017-020396

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Does rearranging meal times at night improve cardiovascular risk factors? An Australian pilot randomised trial in night shift workers.	2021	https://dx.doi.org/10.1016/j.numecd.2021.03.008

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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