Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function

Completed · Not applicable

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT04261881

Run by

Natural Immune Systems Inc

People needed

36

Starts

2018-03-27

Expected to finish

2020-04-08

Last updated by the study team

2020-04-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NIS Labs — Klamath Falls, Oregon, United States

Full record on ClinicalTrials.gov

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