NIS Labs
Klamath Falls, Oregon, 97601, United States
NCT Number: NCT04261881
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Klamath Falls, Oregon, 97601, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 capsules daily with breakfast and 5 capsules daily with lunch
3 capsules daily with breakfast
Time frame: 8 weeks
Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.
Time frame: 8 weeks
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
Time frame: 8 weeks
Thirty-point questionnaire. Each question scores 0-10, max score therefore 300. Change from baseline will be evaluated.
Time frame: 8 weeks
Mean fluorescence
Time frame: 8 weeks
Malondialdehyde level µg/mL
Natural Immune Systems Inc
Other
Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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