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

Trial Summary

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.

What data supports the effectiveness of the treatment Dietary Intervention, Nutritional Counseling, Dietary Therapy for night shift workers' health?

Research shows that dietary interventions, including nutritional counseling, can help shift workers improve their health by reducing energy intake, sugar, and saturated fat, leading to weight loss and better metabolic health. Additionally, these interventions have been associated with improved cholesterol levels and reduced waist circumference, which are important for overall health. ^{1 2 3 4 5}

Is dietary intervention safe for night shift workers?

Dietary interventions, including nutritional counseling and dietary therapy, have been shown to be safe for shift workers. Studies indicate that these interventions can improve health markers like body weight, waist circumference, and metabolic parameters without adverse effects. ^{2 4 6 7 8}

How does the dietary intervention treatment for night shift workers differ from other treatments?

The dietary intervention for night shift workers is unique because it focuses on adjusting meal timing and composition to align better with their disrupted circadian rhythms, aiming to improve metabolic health and reduce risks of diseases like obesity and cardiovascular issues. Unlike other treatments, it emphasizes lifestyle changes through nutritional counseling and dietary adjustments rather than medication. ^{2 3 4 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants. Participants will: * complete 2 inpatient stays * be provided with identical meals * have frequent blood draws * provide urine, saliva, stool and rectal swab samples

Research Team

Frank Scheer, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rotating night shift work and nutrition of nurses and midwives. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

Slim larks and overweight owls? A two years dietary intervention in shift workers. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Interventions for Night Shift Workers: A Literature Review. [2020]

4. Finland pubmed.ncbi.nlm.nih.gov

Eating and shift work - effects on habits, metabolism and performance. [2021]

5. Switzerland 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. [2021]

6. United States 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. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Promote better nutritional behaviours among shift workers with night shift]. [2016]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

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

9. England 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. [2016]