Clinical trial NCT04261881: Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function
Official title: Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fatigue level from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in primary and secondary pain levels from baseline
timeFrame: 8 weeks
Other outcomes:
measure: Change in physical and mental energy, cognitive function and general wellness from baseline
timeFrame: 8 weeks
measure: Change in mitochondrial mass and mitochondrial membrane potential from baseline
timeFrame: 8 weeks
measure: Change in lipid peroxidation from baseline
timeFrame: 8 weeks
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamilton D, Jensen GS. Nutraceutical Support of Mitochondrial Function Associated With Reduction of Long-term Fatigue and Inflammation. Altern Ther Health Med. 2021 May;27(3):8-18.