Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutraceutical intervention, 5 capsules twice daily. | Active Comparator | Participants will consume the nutraceutical blend ATP-Fuel at 5 capsules twice daily. |
|
| Nutraceutical intervention, 3 capsules once daily. | Active Comparator | Participants will consume the nutraceutical blend ATP-II at 3 capsules once daily. |
|
| Nutraceutical intervention, 3 capsules twice daily. | Active Comparator | Participants will consume the nutraceutical blend ATP-II at 3 capsules twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATP-Fuel | Dietary Supplement | 5 capsules daily with breakfast and 5 capsules daily with lunch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue level from baseline | Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical and mental energy, cognitive function and general wellness from baseline | Thirty-point questionnaire. Each question scores 0-10, max score therefore 300. Change from baseline will be evaluated. | 8 weeks |
| Change in mitochondrial mass and mitochondrial membrane potential from baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gitte Jensen, PhD | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33882028 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ATP-II | Dietary Supplement | 3 capsules daily with breakfast |
|
| ATP-II | Dietary Supplement | 3 capsules daily with breakfast and 3 capsules daily with lunch |
|
Mean fluorescence |
| 8 weeks |
| Change in lipid peroxidation from baseline | Malondialdehyde level µg/mL | 8 weeks |