Range of Motion114-012NCT03619265
Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.
A study testing Prickly pear juice and Pear-flavored juice in people with Range of Motion, run by Natural Immune Systems Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Range of Motion
- What is being tested?
- Prickly pear juice and Pear-flavored juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness. A Randomized, Double-blind, Placebo-controlled Clinical Study
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
- Being tested
- Prickly pear juice, Pear-flavored juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prickly pear juiceDietary supplement
3 ounces daily for 8 weeks.
Pear-flavored juiceDietary supplement
3 ounces daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prickly pear juice | Experimental | Prickly pear juice, 3 oz daily for 8 weeks. Receives: Dietary Supplement: Prickly pear juice |
| Pear-flavored juice | Placebo comparator | Pear-flavored juice, 3 oz daily for 8 weeks. Receives: Dietary Supplement: Pear-flavored juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
Measured: Baseline, 2 weeks, and 8 weeks.
Secondary outcomes (1)
Range of motion
Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders.
Measured: Baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start17 Jul 2018
- Primary completion25 Jun 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Range of MotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gitte Jensen, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619265
- Sponsor's protocol ID
- NIS114012
- Acronym
- 114-012
- Status last verified
- Mar 2020
- First submitted
- 10 Jul 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness. A Randomized, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03619265
- Acronym / sponsor ID
- 114-012 / NIS114012
- Conditions
- Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
| Arm | Type | Receives |
|---|---|---|
| Prickly pear juice | Experimental | Dietary Supplement: Prickly pear juicePrickly pear juice, 3 oz daily for 8 weeks. |
| Pear-flavored juice | Placebo comparator | Dietary Supplement: Pear-flavored juicePear-flavored juice, 3 oz daily for 8 weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prickly pear juice3 ounces daily for 8 weeks. | Dietary supplement | Prickly pear juice |
| Pear-flavored juice3 ounces daily for 8 weeks. | Dietary supplement | Pear-flavored juice |
Primary outcome
Pain level
Time frame: Baseline, 2 weeks, and 8 weeks.
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
1 secondary outcome
Range of motion
Time frame: Baseline and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Jensen principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prickly pear juice and Pear-flavored juice in people with Range of Motion, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Baseline, 2 weeks, and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.