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

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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: ATP-Fuel; Dietary supplement: ATP-II; Dietary supplement: ATP-II

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • NIS Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutraceutical intervention, 5 capsules twice daily.; Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily.	Dietary supplement: ATP-Fuel; 5 capsules daily with breakfast and 5 capsules daily with lunch
Active Comparator: Nutraceutical intervention, 3 capsules once daily.; Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily.	Dietary supplement: ATP-II; 3 capsules daily with breakfast; Dietary supplement: ATP-II; 3 capsules daily with breakfast and 3 capsules daily with lunch
Active Comparator: Nutraceutical intervention, 3 capsules twice daily.; Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily.	Dietary supplement: ATP-II; 3 capsules daily with breakfast; Dietary supplement: ATP-II; 3 capsules daily with breakfast and 3 capsules daily with lunch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in mitochondrial mass and mitochondrial membrane potential from baseline	Mean fluorescence	8 weeks
Change in lipid peroxidation from baseline	Malondialdehyde level µg/mL	8 weeks

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Investigators: Principal Investigator: Gitte Jensen, PhD, NIS Labs

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): April 8, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: NIS143-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No