NCT04261881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed
Last Updated

April 14, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 6, 2020

Last Update Submit

April 11, 2020

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in primary and secondary pain levels from baseline

    8 weeks

Other Outcomes (3)

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

    8 weeks

  • Change in mitochondrial mass and mitochondrial membrane potential from baseline

    8 weeks

  • Change in lipid peroxidation from baseline

    8 weeks

Study Arms (3)

Nutraceutical intervention, 5 capsules twice daily.

ACTIVE COMPARATOR

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

Dietary Supplement: ATP-Fuel

Nutraceutical intervention, 3 capsules once daily.

ACTIVE COMPARATOR

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

Dietary Supplement: ATP-II

Nutraceutical intervention, 3 capsules twice daily.

ACTIVE COMPARATOR

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

Dietary Supplement: ATP-II

Interventions

ATP-FuelDIETARY_SUPPLEMENT

5 capsules daily with breakfast and 5 capsules daily with lunch

Nutraceutical intervention, 5 capsules twice daily.
ATP-IIDIETARY_SUPPLEMENT

3 capsules daily with breakfast

Nutraceutical intervention, 3 capsules once daily.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

Related Publications (1)

  • 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.

    PMID: 33882028DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gitte Jensen, PhD

    NIS Labs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

March 27, 2018

Primary Completion

March 16, 2020

Study Completion

April 8, 2020

Last Updated

April 14, 2020

Record last verified: 2020-02

Locations

US(1)