Methylselenocysteine Effects on Circadian Rhythm

Rutgers The State University of New Jersey

Status: Completed

Conditions: Breast Cancer; Prostate Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Methylselenocysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01611038

0220100243

Details and patient eligibility

About

The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.

Full description

All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.

Enrollment: 100 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Permanent night shift schedule

Exclusion criteria

• Nutritional supplements that contain selenium
• Pregnant
• Breast feeding
• Heart conditions
• Chronic lung disease
• Cancer therapy (current or past)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo given daily

Treatment:

Dietary Supplement: Placebo

Methylselenocysteine

Experimental group

Description:

Methylselenocysteine given daily

Treatment:

Dietary Supplement: Methylselenocysteine