Objectives: To evaluate the effects of ATP 360, a nutraceutical energy formula, in people experiencing long-term fatigue affecting daily living. To explore the use of ex vivo mitochondrial stress testing to evaluate cellular energy improvements with nutraceutical support.
Study design: An open-label study design was used with screening for long-term fatigue, scoring 50% or higher on the Piper Fatigue Scale. Eleven participants (8 women, 3 men) consumed the nutraceutical energy formula for 8 weeks, with a 1-week online evaluation and 4-week and 8-week follow-up visits. Eleven healthy people of similar age and BMI range donated blood for comparative evaluation of mitochondrial function in non-fatigued subjects.
Methods: Fatigue scoring was performed using the Piper Fatigue Scale. Other data included blood pressure readings and questionnaires for pain and wellness. Blood draws were performed. Serum was tested for cytokines using bead-based immunoassays. Leukocytes were tested for mitochondrial mass and mitochondrial membrane potential after 2-hour ex vivo inflammatory challenges with bacterial lipopolysaccharide using fluorescent probes, along with flow cytometry analysis.
Primary outcome measures: Change in fatigue and pain levels from baseline to 8 weeks.
Results: Reduction in long-term fatigue was rapid and highly significant after 1 week. Pain reduction reached statistical significance at 4 weeks. Wellness scores improved, especially mental functioning, sleep, increased emotional wellness, and increased energy/vitality. Diastolic blood pressure was reduced. Serum levels of TNF-α and interleukin 8 were reduced. At baseline, leukocyte mitochondrial responses to ex vivo inflammation were low compared to leukocytes from healthy non-fatigued people, showing a mild 21% increase after 4 weeks (not statistically significant), and returning to baseline at 8 weeks.
Conclusion: This proof-of-concept study showed that consumption of a proprietary nutraceutical energy formula resulted in rapid and sustained fatigue reduction associated with reduced pain and inflammatory cytokines and improved wellness. A mild increase in mitochondrial response to inflammation was seen at 4 weeks. A future study with longer duration should evaluate whether mitochondrial function may approach that of a healthy population.
Trial registration: This study was conducted in accordance with the ethical standards set forth in the Helsinki Declaration of 1975 (trial registration number NCT04261881).