Fatigue
Conditions
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.
Interventions
DIETARY_SUPPLEMENTATP-Fuel
5 capsules daily with breakfast and 5 capsules daily with lunch
DIETARY_SUPPLEMENTATP-II
3 capsules daily with breakfast
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in physical and mental energy, cognitive function and general wellness from baseline | 8 weeks | Thirty-point questionnaire. Each question scores 0-10, max score therefore 300. Change from baseline will be evaluated. |
| Change in mitochondrial mass and mitochondrial membrane potential from baseline | 8 weeks | Mean fluorescence |
| Change in lipid peroxidation from baseline | 8 weeks | Malondialdehyde level µg/mL |
Countries
United States
Outcome results
None listed