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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261881
• Other study ID #: NIS143-004
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: April 8, 2020

Study information

• Verified date: February 2020
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• ATP-Fuel
5 capsules daily with breakfast and 5 capsules daily with lunch
• ATP-II
3 capsules daily with breakfast
• ATP-II
3 capsules daily with breakfast and 3 capsules daily with lunch

Locations

Country	Name	City	State
United States	NIS Labs	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

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