Telomeres are the “caps” at the end of DNA that protect cells. Telomeres tend to shorten with age. By examining telomere length in a sample of people with a wide range of ages, we will be able to determine what the typical telomere length is at each age. This research study is to help identify what a “healthy normal” telomere length is at various ages, as well as the telomere length rate of change.

Leukocyte Telomere length (LTL) appears to be an "integrator" of a broad range of current and lifelong factors that impact health, including genetics, diet, fitness, toxins, and chronic stress, and as such, may be the best single biomarker of overall health status. Telomere length is thought to reflect physiological age (body age in years) as well as health status, since studies show that short telomeres accelerate age-related decline and disease in the body.

Therefore, Telome Health seeks to find out a healthy age-related “normal” range of telomere length in order to further our scientific research and be able to provide information and to customers.

About 400 people will take part in this study. We are recruiting healthy individuals from the Bay Area, ages 20-79 through a select number of businesses and by advertising to the public in the local newspaper and other media.

THI is located at: Telome Health, Inc., 1455 Adams Drive, Suite 2036 Menlo Park, CA, 94025. This will be the main study site. However, we may be setting up locations that are more convenient to you, which you will be told about by our study coordinator or on our website.

If you agree, the following procedures will occur.

1. You will take part in an “on-line” screening survey to find out if you are eligible to take part in the main study. The survey will ask you questions based on our selection criteria and also about your current state of health.
2. If the screening survey shows you can take part in the main study and you choose to continue, this is what will happen next:
3. You will be asked to take an on-line survey that will take about 30 minutes to complete. You could also choose to answer the survey in paper format; some of the questions will be personal and sensitive. You are welcome to skip any questions you are uncomfortable with.
4. You will be asked to sign up for an appointment to provide your blood and saliva samples.
5. You will be invited to attend an educational presentation (on-line or in person) at the start of the study.
6. You will go to the study site location to give a blood and saliva sample. The study location will be decided in part by where you live or work to make this as convenient as possible. You will be asked not to eat or drink anything but water before bedtime the night before the blood draw.
7. The blood will be drawn by putting a needle into a vein in your arm. Two small tubes of blood (about 10 teaspoons) will be taken. This will take about 5 minutes. You will also be asked to rinse your mouth and then spit into a saliva collection kit. This will also take about 5 minutes.
8. You will be asked to return to the study site for two more visits to provide blood and saliva samples 6 months and 12 months after the first draw date.
9. You will have the option to learn your own telomere length results at the end of the study. This is because the study itself will be helping us determine what a normal TL and rate of change is for someone of your age.
10. If you decide to learn your personal results, you will also be asked to fill out an online survey from home two months later that will tell us if you found this information useful, as well as any life changes you plan to make because of this information.

You will be enrolled in the study for one year. This includes all 3 visits. Taking part in the study will take about 3 to 4 hours over a period of 12 months. Each test will take around 1 to 1.5 hours. This includes the blood draw, body measures, and completing on-line surveys if they weren’t completed prior to the visit. The actual visit should take less than an hour, and the survey will take about 30 minutes. We strongly recommend that you fill out your survey at home which will greatly shorten your study visit.

With your consent, we plan to store the whole or fractionated saliva and blood samples collected in this study for 20 years. We hope to further research related to telomere biology and potentially develop better tools for assessing health through analysis of additional components of the samples (e.g. serum or plasma biomarkers in blood, stress hormones in saliva, or genetic variations in DNA). These analyses will constitute a new study “Cell Sense 2” and the data may be used to improve future diagnostic tests that THI develops. It is likely that we may contact you if we obtain more detailed information from assessing additional components.

You can stop participating at any time you want. The study coordinator may contact you in order to obtain some final data regarding the study.

• Some of the self-report questions may make you uncomfortable, but you are free to not answer any questions you do not wish to.
• As with any blood draw, the needle stick may hurt. There is a small risk of bruising, and a rare risk of infection at the injection site.
• The information you receive at the end of the study could indicate that you have rather long or short telomeres, or a rather high or low rate of telomere shortening compared to your age group. The meaning of this is not firmly known. You can choose whether or not you want to know that information at the end of the study.

Right now, there are no direct benefits to you as this is a research study, not a treatment study. You will be helping researchers find out how telomere measures might be useful to people and to health care providers. If you choose to, you will learn about your own telomere length and how much they change over one year. There are no proven benefits to learning your telomere length.

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way.

We will do our best to make sure that the personal information gathered for this study is kept as private as possible, however, we cannot guarantee total confidentiality. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

You will not be charged for any of the study treatments or procedures.

In return for your time, effort and travel expenses, you will be paid $50.00 cash after each of the three surveys, a total of $150.00 if you complete this study. This will be given to you after you have completed both the blood draw visit, and the online survey.

hould you be injured as a result of being in the research, please tell the person drawing blood or the study doctor. The cost of any treatment may be covered by THI. For more information please speak with the study doctor.

Telome Health, Inc. (or THI) is paying for this study to take place. THI is a private, for-profit, company that is founded by researchers who study telomere biology and relations to lifestyle. The researchers conducting this study have a “conflict of interest” in that any findings from this study could potentially increase the value of the company.

You can talk to the researcher(s) about the study, your rights as a subject or about the injury policy. You can also ask them about any questions, concerns, or complaints you may have about this study. If you have medical questions that are not answered on our website, please contact THI at 650-250-0289 (ext. 218).
If there are any questions that you feel were not answered to your satisfaction by the THI researchers, you can contact the board that reviewed this study at 1-800-472-3241 or email them at subject@eandireview.com. This board is a group of people that look out for the rights and welfare of research subjects.

Telomere length measurements have not been proven for any medical use by the FDA and they are not a substitute for medical discussion with your primary care physician. Several studies have shown that short telomeres may be a good marker of cardiovascular (heart) disease risk and independent of, and in some cases better than conventional markers. Studies have also suggested that short telomeres are linked with risk of other diseases. However, opting to know or not to know your results is completely your choice. If you would like to know, then our study doctor will go over your test results with you. This information will be for educational purposes only.