Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function

Study Overview
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Brief Summary
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The purpose for this protocol is to perform an open-label human clinical pilot study on the effects of consumption of two nutraceutical blends in subjects with long-term unexplained fatigue interfering with daily living.

Detailed Description
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This is an open-label human clinical study to evaluate the effects of consumption of the nutraceutical product ATP-Fuel, compared to the nutraceutical product ATP-II. The study participants will be randomized to one of three groups: consuming ATP-Fuel (5 capsules, twice daily); consuming ATP-II (3 capsules, once daily); or consuming ATP-II (3 capsules, twice daily). The study is of 8 weeks' duration, with evaluation at baseline, 1, 4, and 8 weeks of product consumption. At each visit the following measurements and procedures are performed: Blood pressure, questionnaires pertaining to fatigue, pain and wellness, and a blood draw. The blood is used for testing of lipid peroxidation and mitochondrial volume and metabolic activity.

Official Title
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Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: ATP-Fuel
* Dietary Supplement: ATP-II
* Dietary Supplement: ATP-II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult people of either gender; Age 18-75 years (inclusive); BMI between 18.0 and 34.9 (inclusive); Experiencing fatigue, at a level that moderately to severely interferes with daily activities, for the past 6 months. Exclusion Criteria: Cancer during past 12 months; Chemotherapy during past 12 months; Currently taking blood thinning medication (81mg aspirin allowed); Getting regular joint injections (such as cortisone shots); Have received a cortisone shot within past 12 weeks; Major surgery within the past 3 months; Major trauma within the past 3 months; Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study; Known food allergies or sensitivities related to the test products; Participation in another research study involving an investigational product in the past month; Planned surgery within 2 weeks of completing the study; Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal]; Unwilling to maintain a constant intake of supplements over the duration of the study; Women who are pregnant, nursing, or trying to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutraceutical intervention, 5 capsules twice daily.<br>Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily. | Dietary Supplement: ATP-Fuel<br>* 5 capsules daily with breakfast and 5 capsules daily with lunch<br>|
| Active Comparator: Nutraceutical intervention, 3 capsules once daily.<br>Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily. | Dietary Supplement: ATP-II<br>* 3 capsules daily with breakfast<br>|
| Active Comparator: Nutraceutical intervention, 3 capsules twice daily.<br>Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily. | Dietary Supplement: ATP-II<br>* 3 capsules daily with breakfast and 3 capsules daily with lunch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue level from baseline | Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in primary and secondary pain levels from baseline | Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated. | 8 weeks |