Dietary Intervention for Night Shift Workers' Health

Overseen By Han-Chow Koh, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Smoking, Drug dependency, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special diet can reduce health problems often faced by night shift workers. Participants will undergo both a dietary intervention (nutritional counseling or dietary therapy) and a control condition, receiving the same meals and providing various health samples. The trial is best suited for healthy individuals aged 18-45, of European, Hispanic, or African-American descent, who do not smoke or have any serious medical conditions. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance the well-being of night shift workers.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants without medical conditions, it's possible that taking medications might affect eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changing the diet of night shift workers is generally safe. A review of five studies involving 670 night shift workers reported no serious side effects. These studies examined how diet could aid in weight management and overall health, finding no harmful effects from dietary changes.

Most participants followed the diets without issues. The main goal was to improve diet quality and maintain healthy eating habits. Although the studies did not lead to weight loss after six or twelve months, they demonstrated that dietary changes are safe and well-tolerated.

Overall, the research suggests that dietary changes for night shift workers are safe and do not cause significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how dietary interventions can specifically support the health of night shift workers, a group often overlooked by traditional healthcare strategies. Unlike standard approaches that might focus on medication or generalized dietary advice, this trial zeroes in on tailored dietary changes that align with the unique challenges faced by night shift workers, like irregular sleep patterns and altered metabolism. By potentially offering a non-pharmaceutical, personalized strategy to improve health outcomes, this approach could pave the way for more effective, lifestyle-based interventions that are both practical and sustainable.

What evidence suggests that this dietary intervention could be effective for night shift workers' health?

Research has shown that changing the diet of night shift workers yields mixed results. A review of five studies involving 670 night shift workers found no weight loss over six or twelve months from dietary changes. However, some studies demonstrated improvements in heart health and metabolism. Another review identified different health outcomes, though specific improvements were not always clear. In this trial, participants will be assigned to either a "Dietary Intervention-Control" arm or a "Control-Dietary Intervention" arm. While the details of the diet plan in this trial remain unknown, past research suggests potential health benefits beyond weight loss. ^{1 3 5 6 7}

Who Is on the Research Team?

Frank Scheer, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18-45 with a BMI of 20.0-29.9, who are of European, Hispanic, or African-American descent. It's not suitable for those with serious health issues, drug/alcohol dependency history, psychiatric disorders, or current/former smokers and vapers.

Inclusion Criteria

I do not have any serious ongoing health issues.

Your body mass index (BMI) is between 20 and 29.9.

You come from European, Hispanic or African-American descent.

Exclusion Criteria

I am currently smoking/vaping or have smoked/vaped for 5+ years.

You have a history of drug or alcohol addiction.

You have a history of mental health problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Stay 1

Participants complete the first inpatient stay with dietary intervention and sample collection

4 days

1 inpatient visit

Inpatient Stay 2

Participants complete the second inpatient stay with dietary intervention and sample collection

4 days

1 inpatient visit

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention

Trial Overview

The study tests if a special diet can reduce the negative effects of working night shifts on health. Participants will have two inpatient stays where they'll eat identical meals and provide blood, urine, saliva, stool and rectal swab samples.

How Is the Trial Designed?

Group I: Dietary intervention-Control Experimental Treatment 1 Intervention

Dietary intervention first, then the Control condition. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes.

Group II: Control-Dietary Intervention Experimental Treatment 1 Intervention

Control condition first, then the Dietary intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Nurses and midwives working rotating night shifts consume significantly more total energy and fatty acids compared to their day-working counterparts, which may increase their risk of overweight and obesity.

The duration of night shift work is associated with lower intake of essential nutrients like calcium and vitamins A and C, indicating potential nutritional deficiencies among night shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotating night shift work and nutrition of nurses and midwives. Peplonska, B., Kaluzny, P., Trafalska, E.[2020]

A study of 65 male shift workers revealed that their dietary intake and eating behaviors were influenced more by the type of shift schedule than by the number of night shifts worked, highlighting the importance of schedule type in dietary patterns.

Specifically, split night shifts and recovery days after night shifts significantly affected both the amount and quality of food consumed, suggesting that tailored dietary interventions are necessary for shift workers to improve their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy, Nutrient and Food Intakes of Male Shift Workers Vary According to the Schedule Type but Not the Number of Nights Worked. Bucher Della Torre, S., Wild, P., Dorribo, V., et al.[2021]

Shift workers face a higher risk of metabolic disorders, such as obesity and cardiovascular disease, which may be linked to poor diet and irregular eating patterns, as well as other factors like disrupted circadian rhythms and sleep deprivation.

The review highlights the need for better dietary assessment and guidelines to improve the nutritional status of shift workers, suggesting that addressing these issues could enhance their overall health and work performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating and shift work - effects on habits, metabolism and performance. Lowden, A., Moreno, C., Holmbäck, U., et al.[2021]

A combined intervention of nutrition education and environmental dietary modification led to significant improvements in dietary intakes, such as reduced saturated fat and salt consumption, and increased nutrition knowledge among employees over a follow-up period of 7-9 months.

The combined approach also resulted in a small but significant reduction in BMI, indicating its potential effectiveness for promoting healthier eating habits and weight loss in the workplace compared to control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of complex workplace dietary interventions on employees' dietary intakes, nutrition knowledge and health status: a cluster controlled trial. Geaney, F., Kelly, C., Di Marrazzo, JS., et al.[2022]

The study found that rotating 3-shift work does not significantly impact the nutritional quality of meals and snacks consumed by shift workers, suggesting that their dietary habits remain stable despite changing work schedules.

Using a qualitative classification system for meals and snacks can be an effective and cost-efficient method for evaluating the eating habits of shift workers, especially when precise quantitative dietary assessments are challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and shiftwork: the use of meal classification as a new tool for qualitative/quantitative evaluation of dietary intake in shiftworkers. Lennernäs, MA., Hambraeus, L., Akerstedt, T.[2016]

A one-year nutritional intervention for 235 night shift workers led to significant improvements in their dietary habits, including reduced intake of sweetened products and salt, and increased water consumption.

The intervention also resulted in increased physical activity levels and decreased daily energy intake, demonstrating that structured dietary counseling can effectively promote healthier behaviors among shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Promote better nutritional behaviours among shift workers with night shift]. Gusto, G., Vol, S., Lasfargues, G., et al.[2016]

A one-year dietary counseling program for 19 male shift workers led to significant improvements in health markers, including reduced energy intake, body weight, and waist circumference, as well as decreased levels of C-reactive protein and triglycerides.

The intervention also resulted in increased melatonin levels, suggesting that dietary changes may positively influence melatonin production, although further research is needed to confirm the long-term health benefits and disease prevention for shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slim larks and overweight owls? A two years dietary intervention in shift workers. Binder-Mendl, C., Ekmekcioglu, C., Marktl, W., et al.[2022]

In a study of 50 middle-aged health workers in Chile, shift workers had a lower carbohydrate intake and higher protein intake compared to day workers, despite similar total energy consumption.

Shift workers exhibited decreased diet quality and irregular eating patterns, highlighting the importance of meal timing and diet quality for future interventions targeting this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Shift Work on the Eating Pattern, Physical Activity and Daytime Sleepiness Among Chilean Healthcare Workers. Farías, R., Sepúlveda, A., Chamorro, R.[2020]

A review of five studies involving 670 night shift workers found that dietary interventions did not lead to weight loss over six or twelve months, but did result in a decrease in LDL-cholesterol levels after six months.

The timing of meals significantly affected metabolic responses, with triglycerides peaking after evening meals and glucose and insulin levels peaking later, indicating that meal timing may play a crucial role in managing cardiometabolic health for night shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Interventions for Night Shift Workers: A Literature Review. Phoi, YY., Keogh, JB.[2020]

Citations

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Dietary Interventions for Night Shift Workers: A Literature Review

Outcomes. The studies in this review measured a range of health outcomes following dietary intervention, including anthropometrics, dietary ...

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Outcome measures were varied but included weight and cardiometabolic health measures. Nutrition programs found no weight improvement at both six ...

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Dietary Intervention for Night Shift Workers' Health

A review of five studies involving 670 night shift workers found that dietary interventions did not lead to weight loss over six or twelve months, but did ...

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The experiences of night shift workers following three different ...

This study aims to explore the experiences of participants while following the interventions to understand how intervention features and external enablers or ...

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A qualitative study on nutrition and well-being of healthcare ...

The results indicate three key themes concerning the nutritional issues and well-being of healthcare shift workers: food intake, sleep quality, ...

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This study aimed to investigate the change in diet quality in addition to dietary adherence to the planetary health diet during night shifts in healthcare ...

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Dietary Interventions for Night Shift Workers: A Literature ...

(1) Background: Night shift workers have greater risks of developing cardiometabolic diseases compared to day workers due to poor sleep quality and dietary ...