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

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ATP-Fuel
ATP-II
ATP-II
Sponsored by
Natural Immune Systems Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NIS Labs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Nutraceutical intervention, 5 capsules twice daily.

Nutraceutical intervention, 3 capsules once daily.

Nutraceutical intervention, 3 capsules twice daily.

Arm Description

Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily.

Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily.

Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily.

Outcomes

Primary Outcome Measures

Change in fatigue level from baseline
Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.

Secondary Outcome Measures

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.

Full Information

First Posted
February 6, 2020
Last Updated
April 11, 2020
Sponsor
Natural Immune Systems Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04261881
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natural Immune Systems Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutraceutical intervention, 5 capsules twice daily.
Arm Type
Active Comparator
Arm Description
Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily.
Arm Title
Nutraceutical intervention, 3 capsules once daily.
Arm Type
Active Comparator
Arm Description
Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily.
Arm Title
Nutraceutical intervention, 3 capsules twice daily.
Arm Type
Active Comparator
Arm Description
Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
ATP-Fuel
Intervention Description
5 capsules daily with breakfast and 5 capsules daily with lunch
Intervention Type
Dietary Supplement
Intervention Name(s)
ATP-II
Intervention Description
3 capsules daily with breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
ATP-II
Intervention Description
3 capsules daily with breakfast and 3 capsules daily with lunch
Primary Outcome Measure Information:
Title
Change in fatigue level from baseline
Description
Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in primary and secondary pain levels from baseline
Description
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change in physical and mental energy, cognitive function and general wellness from baseline
Description
Thirty-point questionnaire. Each question scores 0-10, max score therefore 300. Change from baseline will be evaluated.
Time Frame
8 weeks
Title
Change in mitochondrial mass and mitochondrial membrane potential from baseline
Description
Mean fluorescence
Time Frame
8 weeks
Title
Change in lipid peroxidation from baseline
Description
Malondialdehyde level µg/mL
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte Jensen, PhD
Organizational Affiliation
NIS Labs
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIS Labs
City
Klamath Falls
State/Province
Oregon
ZIP/Postal Code
97601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33882028
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.
Results Reference
derived

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

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