Fatigue Clinical Trial
Official title:
Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function
NCT number | NCT04261881 |
Other study ID # | NIS143-004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 27, 2018 |
Est. completion date | April 8, 2020 |
Verified date | February 2020 |
Source | Natural Immune Systems Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 8, 2020 |
Est. primary completion date | March 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | NIS Labs | Klamath Falls | Oregon |
Lead Sponsor | Collaborator |
---|---|
Natural Immune Systems Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in physical and mental energy, cognitive function and general wellness from baseline | Thirty-point questionnaire. Each question scores 0-10, max score therefore 300. Change from baseline will be evaluated. | 8 weeks | |
Other | Change in mitochondrial mass and mitochondrial membrane potential from baseline | Mean fluorescence | 8 weeks | |
Other | Change in lipid peroxidation from baseline | Malondialdehyde level µg/mL | 8 weeks | |
Primary | 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 | 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 |
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