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

Natural Immune Systems

Status: Completed

Conditions: Fatigue

Treatments: Dietary Supplement: ATP-Fuel; Dietary Supplement: ATP-II

Study type: Interventional

Funder types: Other

Identifiers

NCT04261881

NIS143-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Nutraceutical intervention, 5 capsules twice daily.

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: ATP-Fuel

Nutraceutical intervention, 3 capsules once daily.

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: ATP-II

Dietary Supplement: ATP-II

Nutraceutical intervention, 3 capsules twice daily.

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: ATP-II

Dietary Supplement: ATP-II