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Completed

NCT Number: NCT04261881

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIS Labs

Klamath Falls, Oregon, 97601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATP-Fuel

Dietary Supplement

5 capsules daily with breakfast and 5 capsules daily with lunch

ATP-II

Dietary Supplement

3 capsules daily with breakfast

Primary outcomes

  1. Change in fatigue level from baseline

    Time frame: 8 weeks

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

Secondary outcomes

  1. Change in primary and secondary pain levels from baseline

    Time frame: 8 weeks

    Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.

Other outcomes

  1. Change in physical and mental energy, cognitive function and general wellness from baseline

    Time frame: 8 weeks

    Thirty-point questionnaire. Each question scores 0-10, max score therefore 300. Change from baseline will be evaluated.

  2. Change in mitochondrial mass and mitochondrial membrane potential from baseline

    Time frame: 8 weeks

    Mean fluorescence

  3. Change in lipid peroxidation from baseline

    Time frame: 8 weeks

    Malondialdehyde level µg/mL

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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