The Institute For Molecular Medicine

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Research Clinical Trial Introduction

The most common complaint of patients seeking general medical care is fatigue. Fatigue is also an important symptom of most clinical conditions, and fatigue may also increase with age. Fatigue that has been present for at least six months and is not alleviated by sleep is called chronic fatigue, and chronic fatigue is one of the most common complaints seen today in medical care. Scientists and physicians at the Institute for Molecular Medicine have been conducting research on fatigue, chronic fatigue and a related syndrome called Chronic Fatigue Syndrome (CFS) for over 10 years. Their breakthrough research has resulted in the development of new all-natural food supplements to significantly reduce fatigue.

This clinical trial has been initiated to evaluate a new all-natural product that reduces fatigue. The new product is called ATP Fuel, and it combines three key all-natural components that have been used separately in existing products to treat fatigue and have been found to be completely safe.

A key component of ATP Fuel is NT Factor, a nutrient complex that helps restore healthy cell membranes. Physicians have recommended NT Factor internationally for over 17 years, and over 13 million doses have been administered safely since its release to the public in various products. NT Factor has been evaluated in 6 clinical trials, and has been the focus of more than 25 scientific publications. Other key ingredients that promote energy in ATP Fuel are NADH, an enzyme cofactor that helps in ATP energy production and CoQ10, a powerful antioxidant and cofactor in energy production. ATP Fuel has been especially formulated to optimize energy, increase mitochondrial function and reduce fatigue and tiredness. Mitochondria are the sources of energy production within the cells of your body.

Click to View Past Research on NT Factor

Description of the Clinical Trial

Purpose of the Trial:

The purpose of the study is to determine the effects of ATP Fuel on fatigue levels in the study participants. Participants will be asked to evaluate fatigue levels by filling out a fatigue questionnaire at several intervals during the study.

Criteria for inclusion or exclusion in this study:

Participants recruited for the study are males and females over 18 years of age who consider themselves fatigued and unable to perform normal activities without unusual exertion. Their fatigue levels will be evaluated by their responses to clinical survey questions. Individuals may not qualify for the trial if their fatigue levels are considered at or above the ‘mild fatigue’ energy level. In addition, certain responses to medical questions may exclude them from the trial.

During the survey, participants must NOT use stimulants (drugs or natural stimulates like caffeine), drink energy drinks, or take sleeping pills. If you drink alcohol, this must be done in moderation (no more than 2 drinks per day). Participants can drink coffee, but only in moderate doses (no more than two cups in the morning). Participants who take antidepressants should not stop taking antidepressants without consulting their health care provider. Participants must not have previously taken any dietary supplements containing NT Factor or NADH.

Participants in this study must agree to take the product supplement as requested and be able to take periodic on-line clinical surveys to evaluate their fatigue levels. Eligible participants must also have an email address and telephone number where communications can be received from the Institute for Molecular Medicine.

Procedure:

1. If you decide to volunteer, you will be asked to take a fatigue survey and answer a few questions about your health status before you can be included in the trial.

2. The fatigue survey and responses to the health questions will be screened, and you will be notified by the Institute for Molecular Medicine if you are eligible for the study.

3. After your fatigue survey and health questions have been screened, and you are approved for entry into the trial, you will be notified by telephone or email. A two-month supply of the trial product supplement will be shipped to you at no charge. It should take approximately five business days for you to receive this package after you have been notified of your qualification to enter the trial.

4. Once you receive the trial supplement, you must take the clinical survey on-line to establish a baseline fatigue level (day 0). You should then take five trial supplement capsules 30 minutes before breakfast and five capsules before lunch or dinner (a total of ten capsules per day).

5. After the first week of taking the trial supplement, you will be notified by email to take the second on-line fatigue survey (day 7). You will continue to take the supplement as previously directed.

6. After the first month on the trial supplement, you will be notified to take the third online fatigue survey (day 30). You will continue to take the supplement as previously directed.

7. After the second month on the trial supplement, you will be notified to take the fourth online fatigue survey (day 60). You will then stop taking the supplement and count the remainder of any unused capsules and send this information to the trial office.

8. During the trial you will receive periodic reminders via email that are important to follow. Please check your email regularly.

9. It is important to keep taking the supplement as directed during the entire two-month period of the study.

10. After you have successfully completed the two month study and taken the required surveys, you will receive a three-month supply of ATP Fuel as compensation for participating in the study. You can also receive the results of your fatigue scores calculated after the study is completed.

For further information, please call the survey office and ask for Bob Settineri or Elaine Hyatt – 949-474-0667 or email: clinicaltrials@immed.org

Survey Investigators: Garth Nicolson, PhD and Robert Settineri, MS

Institute for Molecular Medicine, Huntington Beach, California

Sierra Research, Irvine, California