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

NCT03619265 | Completed

• 1 other identifier: NIS114012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain level

  Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.

  Baseline, 2 weeks, and 8 weeks.

Secondary Outcomes (1)

• Range of motion

  Baseline and 8 weeks.

Study Arms (2)

Prickly pear juice

EXPERIMENTAL

Prickly pear juice, 3 oz daily for 8 weeks.

Dietary Supplement: Prickly pear juice

Pear-flavored juice

PLACEBO COMPARATOR

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

Dietary Supplement: Pear-flavored juice

Interventions

Prickly pear juice DIETARY_SUPPLEMENT

3 ounces daily for 8 weeks.

Prickly pear juice

Pear-flavored juice DIETARY_SUPPLEMENT

3 ounces daily for 8 weeks.

Pear-flavored juice

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

Study Officials

• Gitte Jensen

  NIS Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 7, 2018
• Study Start: July 17, 2018
• Primary Completion: June 25, 2019
• Study Completion: February 10, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)