24 Participants Needed

Dietary Intervention for Night Shift Workers' Health

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Overseen ByHan-Chow Koh, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.13567

Who Is on the Research Team?

Frank A.J.L. Scheer | Sleep Medicine

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?
2Treatment groups
Experimental Treatment
Group I: Dietary intervention-ControlExperimental Treatment1 Intervention
Group II: Control-Dietary InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

Dietary Interventions for Night Shift Workers: A Literature ReviewOutcomes. The studies in this review measured a range of health outcomes following dietary intervention, including anthropometrics, dietary ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31547547/
Dietary Interventions for Night Shift Workers: A Literature ...Outcome measures were varied but included weight and cardiometabolic health measures. Nutrition programs found no weight improvement at both six ...
Dietary Intervention for Night Shift Workers' HealthA 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 ...
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 ...
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, ...
Shift Work, Shifted Diets: An Observational Follow-Up ...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 ...
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 ...
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