This study is conducted by the Sleep and Chronobiology Laboratory at the University of Colorado at Boulder.
The microbiome and responsiveness to stress: Countermeasure strategies for improving resilience to sleep and circadian disruption - Insufficient Sleep Microbiome Study Requirements: Healthy Men & Women Age 18-45
This study is about how receiving insufficient sleep changes molecules in your blood, including your blood sugar levels, and alters the bacteria that live in your gut and typically help keep you healthy. We are testing how a prebiotic diet alters how you and the bacteria living in your gut respond to your lifestyle while receiving insufficient sleep. This work will have important implications for the development of treatments and countermeasures for people who do not sleep enough and need to be work in the early morning hours (e.g., emergency and health care workers, military and transportation personnel, service professionals). This research study is part of a larger study examining how a prebiotic diet may alter the gut bacteria and molecules in blood when experiencing sleep restriction and circadian misalignment (being awake when you are supposed to be sleeping).
Prior to the start of this study, there are screening procedures to ensure you meet the criteria for the study. At your first consent screening appointment, you will learn more about the study and answer questionnaires. All of the results of the screening procedures are confidential and will only be used by the study staff to determine eligibility for the study.
Following the screening procedures, you will complete a study which lasts 5 weeks and is mostly done at home. During your home monitoring, we ask you to wear a special watch that records your activity levels. We also ask you to keep a sleep/wake log and use a website to log your daily sleep/wake times (if you cannot access this website, you can call into our answering machine to inform us when you go to bed and wake up each day). For a total of 4 weeks, you will also be provided a powdered prebiotic or maltodextrin placebo that we will ask you to consume once daily, mixed with water. Throughout the study you will be given both a prebiotic and a placebo, but the order of treatment is randomized. It is possible you may receive the prebiotic first and will consume that for two weeks until receiving the placebo second for two weeks. Otherwise you would receive the placebo first for two weeks and will consume that daily until receiving the prebiotic second for two weeks. There will be one week period between the prebiotic and placebo conditions with no supplement or monitoring.
During the home monitoring, you will be outfitted with a Continuous Glucose Monitor which will be placed on the back of your arm, which takes your glucose levels periodically for 14 days at a time. You will have 2 continuous glucose monitors in total.
We will take blood samples on two occasions at our lab to test for immune and metabolic markers. We will also ask you to collect samples of the bacteria that live in your gastrointestinal tract from used bathroom tissue after you use the bathroom on certain days at home during the 4 week study. There are a total of 5 visits that you would need to complete if you are interested in participating in this study, including 1 screening visit and 4 study visits.
If you are eligible to participate in this study, you will be financially compensated for your involvement after the screening procedures. You will be compensated $50 for each week of home activity monitoring and $12.50 for each week of Continuous Glucose Monitoring. The total compensation can be up to $250.
If you are interested in applying to participate in this study, please complete this on-line application survey. We will contact you within one week to let you know if you qualify for the first consent screening appointment. If you need assistance with this survey, have additional questions about the study, or would like to complete the survey via the telephone, please contact us at (303) 735-1923 (M-F, 9am-5pm). With the email address of sleep.study@colorado.edu, general questions can also be answered.
Checking "I agree" documents that you have read the information about the study and give your permission to take part in the initial screening for this research.
* must provide value
I agree
I do not agree
What is your name?
* must provide value
What is your sex?
* must provide value
Female Male
What is your address?
* must provide value
What is your phone number?
* must provide value
What is your email address?
* must provide value
How old are you?
* must provide value
What is your date of birth (MM-DD-YYYY)?
* must provide value
Today M-D-Y
What is your current occupation?
* must provide value
Are you a full time student?
* must provide value
Yes
No
On average, how many hours per week do you work?
* must provide value
What month(s) would you be available to spend 5 consecutive weeks participating in the study?
* must provide value
Have you ever participated in a research study?
* must provide value
Yes No
What type of research study did you participate in?
* must provide value
When did you participate in a research study?
* must provide value
Did the research study involve blood draws? If so, how much blood did you donate?
* must provide value
Did the research study involve taking medication? If so, please list the name of the medication.
* must provide value
How tall are you (feet, inches)?
* must provide value
How much do you weigh (in pounds)?
* must provide value
How long have you weighed this much?
* must provide value
What is the most that you have weighed in your lifetime, excluding pregnancy (in pounds)?
* must provide value
Do you exercise regularly?
* must provide value
Yes No
How often do you exercise?
* must provide value
What type of exercise do you do?
* must provide value
Which is your dominant hand?
* must provide value
Left Right Both
Have you ever been diagnosed with a medical problem or illness?
* must provide value
Yes No
What medical problem(s) or illness(es) have you been diagnosed with, and when did this occur?
* must provide value
Have you ever been diagnosed with a psychological or psychiatric problem or illness?
* must provide value
Yes No
What psychological or psychiatric problem(s) or illness(es) have you been diagnosed with, and when did this occur?
* must provide value
Do you use any prescription medication?
* must provide value
Yes No
Please provide the name of the medication(s), dose, length of use, and the reason you are using it.
* must provide value
Do you use hormones (e.g. contraceptive birth control), inhalers, or medicated patches (e.g. birth control, nicotine)?
* must provide value
Yes No
Please provide the name of the hormone, inhaler, or patch, the dose, how long you have been using it, and for what purpose.
* must provide value
Next is a series of questions about your medical history. Please indicate if you have now or have ever had any of the following conditions. If your response is "Yes" to a question, please explain when the problem was identified or diagnosed, what treatment you use(d) for it and when, and whether you experienced any complications from it.
Have you ever had or do you currently have heart disease or a heart murmur?
* must provide value
Yes No
What heart disease(s) or murmurs have you had? When were they identified? If they are treated, how? Have you had any complications from this?
* must provide value
Have you ever had or do you currently have any type of lung disease?
* must provide value
Yes No
What lung disease(s) have you had? When were they identified? If they are treated, how? Have you had any complications from this?
* must provide value
Have you ever had or do you currently have any type of kidney disease?
* must provide value
Yes No
What kidney disease(s) have you had? When were they identified? If they are treated, how? Have you had any complications from this?
* must provide value
Have you ever had any type of stomach or intestine disease [e.g. ulcers, acid reflux, Irritable Bowl Syndrome (IBS)]?
* must provide value
Yes No
What stomach disease have you had? When were they identified? If they are treated, how? Have you had any complications from this?
* must provide value
Have you ever had and do you currently have any type of visual impairment?
* must provide value
Yes No
What type of visual impairment did you have or do you currently have?
* must provide value
Do you wear contact lenses or glasses?
* must provide value
Yes No
What type of corrective lenses do you use?
* must provide value
Primarily contact lenses Primarily eyeglasses Both contact lenses and eyeglasses
Have you had any eye injuries?
* must provide value
Yes No
What type of eye injury have you had? When did this occur? If it was treated, how? Have you had any complications from this?
* must provide value
Are you colorblind?
* must provide value
Yes No I don't know
What type of colorblindness do you have?
* must provide value
Do you have any hearing impairments?
* must provide value
Yes No
What type of hearing impairment do you have?
* must provide value
Have you ever had any type of neurological disease (e.g. stroke, seizures, migraine headaches)?
* must provide value
Yes No
What type of neurological disease have you had? When was it identified? If it is treated, how? Have you had any complications from this?
* must provide value
Have you ever been diagnosed with peripheral neuropathy associated with cold intolerance, numbness and skin color changes in the hands, complex regional pain syndrome (CRPS), Raynaud phenomenon, occlusive vascular disease of the hand, acrocyanosis, erythromelalgia, or metabolic or autoimmune diseases that affect digital blood flow?
* must provide value
Yes No
Have you experienced accidents, head injuries, concussions, or loss of consciousness?
* must provide value
Yes No
What was the nature of your accident, head injury, or concussion? What length of time did you lose consciousness for, if at all? When did the incident occur, what (if any) treatment have you undergone for it, and have you experienced any long term complications because of it?
* must provide value
Have you ever had or do you currently have thyroid disease (e.g. hyper or hypothyroidism)?
* must provide value
Yes No
What type of thyroid disease have you had? When was it identified? If it is treated, how?
* must provide value
Have you had or do you have high blood pressure?
* must provide value
Yes No
Do you have diabetes?
* must provide value
Yes No
Do you have hepatitis?
* must provide value
Yes No I don't know
What type of hepatitis do you have?
* must provide value
Have you ever had or do you now have asthma?
* must provide value
Yes No
Has your asthma been influenced by age, physical activity, or temperature? How do you manage or treat it?
* must provide value
Have you ever had surgery?
* must provide value
Yes No
What type of surgery? When? Was local or general anesthesia used? Did you have any complications following the surgery?
* must provide value
What type of caffeine do you typically consume? (Check all that apply)
* must provide value
coffee - caffeinated
tea - caffeinated
soft drinks
energy drinks
chocolate
I do not consume any caffeine
How much caffeinated coffee do you drink and how often? Please specify the size of the drink (e.g. 8 oz., or Starbucks Grande size), and the number you consume per day, week, or month.
* must provide value
How much caffeinated tea do you drink and how often? Please specify the size of the drink (e.g. 8 oz., or 1 mug) and the number you consume per day, week, or month.
* must provide value
How many caffeinated soft drinks do you consume, and how often? Please specify the size of the drink (e.g. one 12 ounce can or one 20 ounce bottle) and how many you consume per day, week, or month.
* must provide value
Please specify the energy drink you use, the size, and how many you consume per day, week, or month.
* must provide value
How much chocolate do you eat and how often?
* must provide value
Please indicate if you use the following: (check all that apply)
Sedatives (i.e. valium, sleeping pills, anti-anxiety pills)
Antihistamines (i.e. allergy medicine)
Pain relievers (e.g. Aspirin, Tylenol, Ibuprofen)
Antacids
What type of sedatives do you use, what dose, how often, and for what purpose?
What antihistamines do you use, what dose, how frequently, and for what purpose?
What type of pain reliever do you use, what dose, how frequently, and for what purpose?
What type of antacid do you use, how frequently, and for what purpose?
Do you drink alcohol?
* must provide value
Yes No
On average, how many days per week do you drink alcohol, and how much do you drink on each occasion?
* must provide value
Do you ever use tobacco?
* must provide value
Yes No
What type of tobacco do you use? (check all that apply)
* must provide value
Chewing tobacco
Cigarettes
Cigars
Pipe
Hookah
How long have you chewed tobacco, how much, and how often do you chew?
* must provide value
How long have you smoked cigarettes, how many cigarettes do you smoke per day, and have you ever quit smoking (if yes, provide details like when and for how long you stopped)?
* must provide value
How long have you smoked cigars, pipe tobacco, or hookah and how much do you smoke per day?
* must provide value
Do you currently use marijuana?
* must provide value
Yes
No
How long have you used marijuana, how much, and how often?
* must provide value
Do you have any problems with your sleep?
* must provide value
Yes No
What type of problems do you have with your sleep?
* must provide value
How long does it usually take you to fall asleep?
* must provide value
How many hours do you sleep in an average night?
* must provide value
What is your usual bedtime on weekdays?
* must provide value
What is your usual wake time on weekdays?
* must provide value
What is your usual bedtime on weekends?
* must provide value
What is your usual wake time on weekends?
* must provide value
Do you ever take naps?
* must provide value
Yes
No
How many naps do you take during a week? How long is each nap?
* must provide value
Have you traveled outside of the mountain time zone within the past 3 months?
* must provide value
Yes No
Where did you go, for how many days, and what date did you return?
* must provide value
Do you have future travel plans that may conflict with participation in this study; if so, when, for how many days, and to where?
* must provide value
As of today, how long have you lived at the altitude of Denver or higher?
* must provide value
How did you hear about this research study?
* must provide value
CU Boulder Buff Bulletin CU Boulder Today Craigslist Indeed Research Match Reddit Facebook Online Banner Ad (Various Websites) Flyer Word of mouth Other
Do you use hormonal contraceptives?
* must provide value
Yes No
What type of hormonal contraceptive do you use?
* must provide value
How long have you been using this hormonal contraceptive?
* must provide value
How many days are there from the start of one menstrual period to the start of the next menstrual period for you?
* must provide value
What was the start date of your last menstrual cycle?
* must provide value
Today M-D-Y
What was the start date of your menstrual cycle prior to that? (e.g. your second-to-last menstrual cycle)
* must provide value
Today M-D-Y
Is the number of days between your menstrual period consistent from month to month?
* must provide value
Yes No
Please explain how the length of time between your menstrual periods varies from month to month.
* must provide value
Have you given birth in the past year?
* must provide value
Yes No
Are you currently breastfeeding?
* must provide value
Yes No
Please check all of the following dietary descriptions that apply to you:
* must provide value
Vegetarian
Vegan
Gluten sensitivity or allergy
Dairy sensitivity or allergy
Other food allergies, sensitivities or restrictions
No food allergies, sensitivities or restrictions
I give my permission for my information to be included in the study recruitment database to take part in other current studies I may qualify for, or for future research.
* must provide value
Yes No
Initials
* must provide value
If I answered yes, I understand that I may later change my mind, and that I can contact the Sleep and Chronobiology Staff in writing to have my contact information destroyed.
Submit
Save & Return Later