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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000791336
Enrollment
19
Registered
2017-05-30
Start date
2017-08-24
Completion date
2018-07-11
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 redistrib

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.

Sponsors

A/Prof Maxine Bonham
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026