Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fatigue
- Sponsor
- Natural Immune Systems Inc
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in fatigue level from baseline
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Change in fatigue level from baseline
Time Frame: 8 weeks
Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.
Secondary Outcomes
- Change in primary and secondary pain levels from baseline(8 weeks)