Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function
NCT ID: NCT04261881
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2018-03-27
2020-04-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Nutraceutical intervention, 5 capsules twice daily.
Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily.
ATP-Fuel
5 capsules daily with breakfast and 5 capsules daily with lunch
Nutraceutical intervention, 3 capsules once daily.
Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily.
ATP-II
3 capsules daily with breakfast
Nutraceutical intervention, 3 capsules twice daily.
Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily.
ATP-II
3 capsules daily with breakfast and 3 capsules daily with lunch
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Natural Immune Systems Inc
OTHER
Responsible Party
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Principal Investigators
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Gitte Jensen, PhD
Role: PRINCIPAL_INVESTIGATOR
NIS Labs
Locations
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NIS Labs
Klamath Falls, Oregon, United States
Countries
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References
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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.
Other Identifiers
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NIS143-004
Identifier Type: -
Identifier Source: org_study_id
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