Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097474
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2004-11-23
Brief Title:
Effects of Hydrocortisone Melatonin and Placebo on Jet Lag
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Hydrocortisone Melatonin and Placebo on Symptoms of Jet Lag
Status:
COMPLETED
Status Verified Date:
2024-07-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of cortisol hydrocortisone melatonin a combination of cortisol and melatonin and placebo an inactive substance on jet lag symptoms Jet lag is a term used to describe symptoms people commonly experience after rapid travel across several time zones The cause of jet lag is not known but various hormones including cortisol and melatonin have a day-to-night pattern of secretion and play a role in maintaining the bodys internal rhythms This study will test whether taking cortisol melatonin or both can help re-establish the bodys day-night cycle and result in less jet lag
People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study
Crossing six to eight time zones 6 to 8 hours difference between Eastern Standard Time and the destination
Destination between 30 and 50 latitudes approximately Cairo to London
Evening flight 5 PM to midnight with morning arrival
Remaining abroad at least 4-10 days
Candidates must have a body mass index BMI between 20 and 30 kgM not too thin and not overweight and must not be taking medicines that affect sleep or cortisol or melatonin levels Prospective participants are screened with a medical history blood tests and check of blood pressure height and weight
Pre-flight Procedures
Participants keep a sleep journal 3 days before the flight For 1 day within 3 days of the flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime saliva samples for measurement of cortisol and melatonin The saliva is collected by chewing on two small cotton pads and spitting them into a tube Premenopausal women provide a urine sample the week before the flight to test for pregnancy On the day of the flight the participants do not collect saliva or fill out sleep logs or questionnaires They are given two bottles with study medication One bottle labeled AM contains either hydrocortisone or placebo the other labeled PM contains either melatonin or placebo
Post-flight Procedures
Upon arriving at their destination in the morning participants obtain a saliva sample and take one of the capsules in the AM bottle At bedtime they collect saliva and then take one of the PM capsules They repeat the medication doses for a total of 4 days and repeat the saliva collections on days 2 through 4 7 and 10 after arrival In addition participants complete jet lag and sleep questionnaires in the morning afternoon and just before bedtime on the day of arrival and on days 2 through 4 7 and 10
After they return from their trip participants are seen at the NIH Clinic to bring in their saliva specimens and review their questionnaires with study investigators
People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study
Crossing six to eight time zones 6 to 8 hours difference between Eastern Standard Time and the destination
Destination between 30 and 50 latitudes approximately Cairo to London
Evening flight 5 PM to midnight with morning arrival
Remaining abroad at least 4-10 days
Candidates must have a body mass index BMI between 20 and 30 kgM not too thin and not overweight and must not be taking medicines that affect sleep or cortisol or melatonin levels Prospective participants are screened with a medical history blood tests and check of blood pressure height and weight
Pre-flight Procedures
Participants keep a sleep journal 3 days before the flight For 1 day within 3 days of the flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime saliva samples for measurement of cortisol and melatonin The saliva is collected by chewing on two small cotton pads and spitting them into a tube Premenopausal women provide a urine sample the week before the flight to test for pregnancy On the day of the flight the participants do not collect saliva or fill out sleep logs or questionnaires They are given two bottles with study medication One bottle labeled AM contains either hydrocortisone or placebo the other labeled PM contains either melatonin or placebo
Post-flight Procedures
Upon arriving at their destination in the morning participants obtain a saliva sample and take one of the capsules in the AM bottle At bedtime they collect saliva and then take one of the PM capsules They repeat the medication doses for a total of 4 days and repeat the saliva collections on days 2 through 4 7 and 10 after arrival In addition participants complete jet lag and sleep questionnaires in the morning afternoon and just before bedtime on the day of arrival and on days 2 through 4 7 and 10
After they return from their trip participants are seen at the NIH Clinic to bring in their saliva specimens and review their questionnaires with study investigators
Detailed Description:
Jet lag resulting from rapid flight across several time zones is a common complaint of travelers The symptoms of jet lag are primarily described as daytime sleepiness fatigue and impaired mental efficiency and can also include weakness and irritability It is considered to be due to the desynchronization between the internal circadian rhythm and the new local day-night cycle at the traveler s destination A means of rapidly resynchronizing the circadian rhythm to the local time would benefit people who suffer severely from this syndrome
What actually underlies jet lag is a question that has not been fully answered Various endogenous hormones including cortisol and melatonin have a natural circadian rhythmicity and play a role in maintaining the body s internal clock Cortisol is produced by the hypothalamic- pituitary-adrenal axis in a circadian manner and in response to stress Normal cortisol has a diurnal rhythm with a maximum level in the morning and a nadir during the night While a time shift does not change the total daily amount of cortisol that is secreted the temporal organization of the cortisol secretions is disrupted and the circadian rhythm does not re-entrain for several days Thus the first few mornings in a new time zone can be considered relatively cortisol-deficient because the traveler does not experience the peak of cortisol at the time of awakening Taking exogenous glucocorticoids at the proper time may help re-entrain the circadian rhythm faster and result in less jet lag
Melatonin is a hormone that is secreted nocturnally by the pineal gland Exposure to bright light diminishes its release while darkness triggers it A recent meta-analysis has shown that taking melatonin can alleviate symptoms of jet lag
The aim of the present study is an attempt for the first time to attenuate jet lag symptoms with hydrocortisone melatonin a combination of both hydrocortisone and melatonin or placebo
Forty-eight normal volunteers will be randomized in blocks of eight to one of four treatment arms hydrocortisone 25 mg alone melatonin 5 mg alone hydrocortisone 25 mg and melatonin 5 mg in combination and placebo Volunteers will travel in an eastwardly direction across 6-8 time zones Upon morning arrival at the new destination volunteers will obtain a saliva sample and then take 25 mg hydrocortisone or placebo At the target bedtime of 10 pm to midnight local time they will take 5 mg of melatonin or placebo Volunteers will wake up at 7 am-1030 am local time and take 25 mg hydrocortisone or placebo Subjects will repeat these dosages for 3 days for a total of four days Participants also will obtain salivary samples of cortisol and melatonin on awakening and at bedtime on one day before travel and at the new destination for days 1 - 4 7 and 10 after arrival The primary outcome measure will be subjective rating of jet lag and components or correlates of this such as fatigue and daytime tiredness Subjects will keep sleep logs and fill out a symptoms questionnaire daily for 3 days before and 4 days after the flight and on days 7 and 10 Secondary outcomes will be the measurement of salivary cortisol and melatonin The data obtained from this study will provide an assessment of effective treatment of jet lag syndrome and will provide a better understanding of the role of hormones in the disruption of the circadian rhythm
What actually underlies jet lag is a question that has not been fully answered Various endogenous hormones including cortisol and melatonin have a natural circadian rhythmicity and play a role in maintaining the body s internal clock Cortisol is produced by the hypothalamic- pituitary-adrenal axis in a circadian manner and in response to stress Normal cortisol has a diurnal rhythm with a maximum level in the morning and a nadir during the night While a time shift does not change the total daily amount of cortisol that is secreted the temporal organization of the cortisol secretions is disrupted and the circadian rhythm does not re-entrain for several days Thus the first few mornings in a new time zone can be considered relatively cortisol-deficient because the traveler does not experience the peak of cortisol at the time of awakening Taking exogenous glucocorticoids at the proper time may help re-entrain the circadian rhythm faster and result in less jet lag
Melatonin is a hormone that is secreted nocturnally by the pineal gland Exposure to bright light diminishes its release while darkness triggers it A recent meta-analysis has shown that taking melatonin can alleviate symptoms of jet lag
The aim of the present study is an attempt for the first time to attenuate jet lag symptoms with hydrocortisone melatonin a combination of both hydrocortisone and melatonin or placebo
Forty-eight normal volunteers will be randomized in blocks of eight to one of four treatment arms hydrocortisone 25 mg alone melatonin 5 mg alone hydrocortisone 25 mg and melatonin 5 mg in combination and placebo Volunteers will travel in an eastwardly direction across 6-8 time zones Upon morning arrival at the new destination volunteers will obtain a saliva sample and then take 25 mg hydrocortisone or placebo At the target bedtime of 10 pm to midnight local time they will take 5 mg of melatonin or placebo Volunteers will wake up at 7 am-1030 am local time and take 25 mg hydrocortisone or placebo Subjects will repeat these dosages for 3 days for a total of four days Participants also will obtain salivary samples of cortisol and melatonin on awakening and at bedtime on one day before travel and at the new destination for days 1 - 4 7 and 10 after arrival The primary outcome measure will be subjective rating of jet lag and components or correlates of this such as fatigue and daytime tiredness Subjects will keep sleep logs and fill out a symptoms questionnaire daily for 3 days before and 4 days after the flight and on days 7 and 10 Secondary outcomes will be the measurement of salivary cortisol and melatonin The data obtained from this study will provide an assessment of effective treatment of jet lag syndrome and will provide a better understanding of the role of hormones in the disruption of the circadian rhythm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-0037 | None | None | None |