Methylselenocysteine Effects on Circadian Rhythm

Breast Cancer Clinical Trial

Official title:

Chemoprevention of Breast and Prostate Cancers in Shift Workers by Dietary Methylselenocysteine: Effects on Circadian Rhythm and Estrogen Receptor-B Cycling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611038
• Other study ID #: 0220100243
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: September 11, 2017
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: September 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Methylselenocysteine
Methylselenocysteine capsule given daily
• Placebo
Placebo capsule given daily

Locations

Country	Name	City	State
United States	Environmental and Occupational Health Sciences Institute	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers		30 days