Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function
- Conditions
- Fatigue
- Interventions
- Dietary Supplement: ATP-FuelDietary Supplement: ATP-II
- Registration Number
- NCT04261881
- Lead Sponsor
- Natural Immune Systems Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutraceutical intervention, 5 capsules twice daily. ATP-Fuel Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily. Nutraceutical intervention, 3 capsules once daily. ATP-II Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily. Nutraceutical intervention, 3 capsules twice daily. ATP-II Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily.
- Primary Outcome Measures
Name Time Method Change in fatigue level from baseline 8 weeks Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.
- Secondary Outcome Measures
Name Time Method Change in primary and secondary pain levels from baseline 8 weeks Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
Trial Locations
- Locations (1)
NIS Labs
🇺🇸Klamath Falls, Oregon, United States