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

Not Applicable

Completed

• Conditions: Fatigue

• 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.

Study Timeline

• Study Start: 2018-03-27
• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Primary Completion: 2020-03-16
• Study Completion: 2020-04-08
• Last Update Submitted: 2020-04-11
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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