NCT04261881

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Natural Immune Systems Inc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ATP-Fuel	5 capsules daily with breakfast and 5 capsules daily with lunch
DIETARY_SUPPLEMENT	ATP-II	3 capsules daily with breakfast
DIETARY_SUPPLEMENT	ATP-II	3 capsules daily with breakfast and 3 capsules daily with lunch

Timeline

• Start date: 2018-03-27
• Primary completion: 2020-03-16
• Completion: 2020-04-08
• First posted: 2020-02-10
• Last updated: 2020-04-14

Locations

1 site across 1 country: United States