Methylselenocysteine Effects on Circadian Rhythm

Not Applicable

Completed

• Conditions: Breast Cancer; Prostate Cancer
• Interventions: Dietary Supplement: Methylselenocysteine; Dietary Supplement: Placebo

• Registration Number: NCT01611038
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-06-04
• Primary Completion: 2013-07
• Study Completion: 2015-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylselenocysteine	Methylselenocysteine	Methylselenocysteine given daily
Placebo	Placebo	Placebo given daily

Primary Outcome Measures

Name	Time	Method
Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers	30 days

Trial Locations

Locations (1)

Environmental and Occupational Health Sciences Institute; 🇺🇸 Piscataway, New Jersey, United States