FatigueNCT04261881
Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function
A study testing ATP-Fuel and ATP-II in people with Fatigue, run by Natural Immune Systems Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- ATP-Fuel and ATP-II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 8 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- ATP-Fuel, ATP-II
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATP-FuelDietary supplement
5 capsules daily with breakfast and 5 capsules daily with lunch
ATP-IIDietary supplement
3 capsules daily with breakfast
ATP-IIDietary supplement
3 capsules daily with breakfast and 3 capsules daily with lunch
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical intervention, 5 capsules twice daily. | Active comparator | Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily. Receives: 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. Receives: 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. Receives: Dietary Supplement: ATP-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue level from baseline
Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start27 Mar 2018
- Primary completion16 Mar 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gitte Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261881
- Sponsor's protocol ID
- NIS143-004
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33882028
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function
- ClinicalTrials.gov ID
- NCT04261881
- Acronym / sponsor ID
- NIS143-004
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical intervention, 5 capsules twice daily. | Active comparator | Dietary Supplement: ATP-FuelParticipants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily. |
| Nutraceutical intervention, 3 capsules once daily. | Active comparator | Dietary Supplement: ATP-IIParticipants will consume the nutraceutical blend ATP-II at 3 capsules once daily. |
| Nutraceutical intervention, 3 capsules twice daily. | Active comparator | Dietary Supplement: ATP-IIParticipants will consume the nutraceutical blend ATP-II at 3 capsules twice daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATP-Fuel5 capsules daily with breakfast and 5 capsules daily with lunch | Dietary supplement | Nutraceutical intervention, 5 capsules twice daily. |
| ATP-II3 capsules daily with breakfast | Dietary supplement | Nutraceutical intervention, 3 capsules once daily. |
| ATP-II3 capsules daily with breakfast and 3 capsules daily with lunch | Dietary supplement | Nutraceutical intervention, 3 capsules twice daily. |
Primary outcome
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.
1 secondary outcome
Change in primary and secondary pain levels from baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 33882028Hamilton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Jensen, PhD principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATP-Fuel and ATP-II in people with Fatigue, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue level from baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.