Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.

NCT ID: NCT03619265

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2020-02-10

Brief Summary

The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled, parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on physical and mental energy levels and overall wellness.

Conditions

Range of Motion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Prickly pear juice

Prickly pear juice, 3 oz daily for 8 weeks.

Group Type: EXPERIMENTAL

Prickly pear juice

Intervention Type: DIETARY_SUPPLEMENT

3 ounces daily for 8 weeks.

Pear-flavored juice

Pear-flavored juice, 3 oz daily for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Pear-flavored juice

Intervention Type: DIETARY_SUPPLEMENT

3 ounces daily for 8 weeks.

Interventions

Prickly pear juice

3 ounces daily for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Pear-flavored juice

3 ounces daily for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy adults of either gender;
• 35-75 years old;
• Chronic joint/muscle related pain for at least past 6 months;
• Body mass index (BMI) at or below 34.9 kg/m2.

Exclusion Criteria

• Bariatric surgery;
• Diagnosed with diabetes Type I;
• Taking medication for diabetes Type II;
• Known serious chronic health condition;
• Serious active illness within past 12 months;
• Major surgery within the past 3 months;
• Major trauma within the past 3 months;
• Alcohol consumption of more than four standard units/day (for example more than four regular 12 oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits), or more than 28 units per week;
• Daily consumption of Nopalea or similar juice products during the past month;
• Currently taking anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
• Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable);
• Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
• 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;
• Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
• Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
• Known allergies to ingredients in the test and placebo products.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Immune Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gitte Jensen

Role: PRINCIPAL_INVESTIGATOR

NIS Labs

Locations

NIS Labs

Klamath Falls, Oregon, United States

Countries

United States

Other Identifiers

NIS114012

Identifier Type: -

Identifier Source: org_study_id