ArthralgiaNCT02589249
The Effect of AyuFlex® Supplementation on Joint Health
A study testing AyuFlex in people with Arthralgia, run by The Center for Applied Health Sciences, LLC.
Trial summary
The purpose of this 12-week, prospective study is to determine the effects of oral supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility, joint comfort and functional capacity in healthy overweight subjects. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthralgia
- What is being tested?
- AyuFlex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 7 Feb 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers >35 to <70 years of age.
- Non-smoker.
- Body Mass Index (BMI) greater than 30 kg/m2 and less than 45 kg/m2 at screening.
- Willing to maintain current background dietary and physical activity pattern throughout study period.
- Knee joint:
- No knee joint discomfort at rest.
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- Experience knee joint discomfort with activity or exercise within the last 2 weeks of at least 30 mm out of 100mm on VAS rating for "knee discomfort with activity or exercise at any time over the last 3 weeks".
- Must achieve a rating of at least 30mm on a 100mm VAS at any point throughout the standardized lower extremity exercise performance screening test (Screening test = 3 sets of 10-12 repetitions on seated knee extension machine + 3-minute walk test at maximal walking velocity).
- Non-pregnant, non-lactating females who agree to use effective contraceptive methods throughout the course of the study.
- Females of childbearing potential must agree to use one of the following acceptable birth control methods:
- Surgically sterile (hysterectomy or bilateral oophorectomy);
- Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation);
- Intrauterine device (IUD) in place for at least 3 months;
- Abstinence (not having sexual intercourse);
- Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion;
- Vasectomized partner.
- Able to understand study procedures and provide signed informed consent, and authorizes release of relevant health information to study investigator.
- Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
- Females of childbearing potential must have a negative urine pregnancy test at screening.
Who cannot join
- Subjects with an established diagnosis of inflammatory joint disorder or osteoarthritis per ACR (American College of Rheumatology) guidelines.
- Currently taking, or chronic use within 30 days of anti-inflammatory supplements, Boswellia, Curcumin, Omega-3 fatty acids, Glucosamine, Chondroitin, MSM, or Collagen supplements of any type.
- Daily use of NSAIDs (non-steroidal anti-inflammatory drugs); however, daily use of 81 mg of aspirin (not > 81 mg) for cardioprotection is allowed.
- Upon physical screening by the medical staff, any subject with signs of overt nutrient deficiencies or metabolic abnormalities such as anemia. This will also need to be included in the screening assessment.
- Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with walking or exercise testing utilized throughout the study.
- Glucocorticoid (Corticosteroid) injection, hyaluronic acid injection, prolotherapy, or PRP (platelet rich plasma) injection, bone marrow or other regenerative injection in affected knee within 6 months prior to enrollment in study.
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- Individual has any recent illness or condition (within 6 months of screening) that the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or might confound the interpretation of the study results or put the person at undue risk.
- Known or suspected pregnancy, planned pregnancy, or lactation.
- If the subjects has been treated for any psychiatric illness or hospitalized for such within the past year, upon PI discretion, will be excluded from the study.
- History of allergic reaction or known sensitivity to Terminalia chebula or other chemically related botanical/ herbal products or supplements.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
- Vital sign abnormalities (seated, resting systolic blood pressure lower than 90 or higher than 150 mmHg, diastolic blood pressure lower than 50 or higher than 100 mmHg, or heart rate less than 50 or more than 110 bpm) at screening.
- History or clinically significant gastrointestinal disorder, (eg, inflammatory bowel diseases), presence of any gastrointestinal pathology, persistent gastrointestinal symptoms (eg, diarrhea, vomiting), liver or kidney disease, gastric bypass, gastric stapling, use of Lapband, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of dietary supplements.
- History of active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic/ autoimmune, psychiatric, or metabolic disease that is considered clinically significant by the PI.
- Recent history of (within past 12 months), or strong potential for, alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits).
- Exposure to any investigational agent or drug product within 30 days prior to study entry.
- Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
- Individual has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
About this study
Official title: The Effect of AyuFlex® Dietary Supplementation on Joint Mobility, Comfort and Functional Capacity in Healthy Overweight Subjects
The purpose of this 12-week, prospective study is to determine the effects of oral supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility, joint comfort and functional capacity in healthy overweight subjects.
Read the detailed description
This interventional study is a 12-week, randomized, double-blind, placebo and dose-response controlled clinical trial (in 3 parallel groups) of male and female subjects without active osteoarthritis of the knee to be recruited at a single investigational center in the U.S. A two-week placebo lead-in period will precede the study to enhance statistical power. One-hundred and five (105) overweight, apparently healthy subjects, pre-screened using health history questionnaires, vital signs, blood work and a standardized lower extremity exercise performance test will be randomized to one of three groups for 84 days: placebo, AyuFlex1 (500 mg/d) or AyuFlex2 (1000 mg/d). AyuFlex is an organic, non-GMO, over-the-counter joint health product derived from the edible fruits of Terminalia chebula.
- Conditions
- Arthralgia
- Being tested
- AyuFlex, Placebo
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyuFlexDietary supplement
Active product
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
| AyuFlex1 | Active comparator | AyuFlex1 (500 mg/d) Receives: Dietary Supplement: AyuFlex |
| AyuFlex2 | Active comparator | AyuFlex2 (1000 mg/d) Receives: Dietary Supplement: AyuFlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Change in score from Day 0 to day 14, 42, and 84
Visual Analogue Scale scores for discomfort, mobility, disability
Measured: Change in score from Day 0 to day 14, 42, and 84
Secondary outcomes (5)
Inflammatory biomarkers
tumor necrosis factor-alpha, c-reactive protein, and cartilage oligomeric matrix protein
Measured: Change from Day 0 to 84
6 minute walk test
Total distance covered in 6 minutes
Measured: Change in score from Day 0 to day 14, 42, and 84
Range of motion of pain-free knee flexion/extension
Measured: Change from Day 0 to 84
Blood chemistry
Comprehensive metabolic panel, CBC, lipid panel
Measured: Change from Day 0 to 84
Vital signs
Resting heart rate and blood pressure
Measured: Change in score from Day 0 to day 14, 42, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthralgiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Natreon, Inc.
- Responsible party
- Sponsor
- Investigators
- Tim N Ziegenfuss, PhD, Principal investigator, The Center for Applied Health Sciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589249
- Sponsor's protocol ID
- NATAF-001-2015
- Status last verified
- Apr 2017
- First submitted
- 26 Oct 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lopez HL, Habowski SM, Sandrock JE, Raub B, Kedia A, Bruno EJ, Ziegenfuss TN. Effects of dietary supplementation with a standardized aqueous extract of Terminalia chebula fruit (AyuFlex(R)) on joint mobility, comfort, and functional capacity in healthy overweight subjects: a randomized placebo-controlled clinical trial. BMC Complement Altern Med. 2017 Oct 2;17(1):475. doi: 10.1186/s12906-017-1977-8.
PubMed 28969626
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AyuFlex® Dietary Supplementation on Joint Mobility, Comfort and Functional Capacity in Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT02589249
- Acronym / sponsor ID
- NATAF-001-2015
- Conditions
- Arthralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Natreon, Inc.
- Study start
- Nov 2015
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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 of this 12-week, prospective study is to determine the effects of oral supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility, joint comfort and functional capacity in healthy overweight subjects.
Detailed description
This interventional study is a 12-week, randomized, double-blind, placebo and dose-response controlled clinical trial (in 3 parallel groups) of male and female subjects without active osteoarthritis of the knee to be recruited at a single investigational center in the U.S. A two-week placebo lead-in period will precede the study to enhance statistical power. One-hundred and five (105) overweight, apparently healthy subjects, pre-screened using health history questionnaires, vital signs, blood work and a standardized lower extremity exercise performance test will be randomized to one of three groups for 84 days: placebo, AyuFlex1 (500 mg/d) or AyuFlex2 (1000 mg/d). AyuFlex is an organic, non-GMO, over-the-counter joint health product derived from the edible fruits of Terminalia chebula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo |
| AyuFlex1 | Active comparator | Dietary Supplement: AyuFlexAyuFlex1 (500 mg/d) |
| AyuFlex2 | Active comparator | Dietary Supplement: AyuFlexAyuFlex2 (1000 mg/d) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Healthy male or female volunteers >35 to <70 years of age.
- Non-smoker.
- Body Mass Index (BMI) greater than 30 kg/m2 and less than 45 kg/m2 at screening.
- Willing to maintain current background dietary and physical activity pattern throughout study period.
- Knee joint:
Key exclusion criteria (18 listed)
- Subjects with an established diagnosis of inflammatory joint disorder or osteoarthritis per ACR (American College of Rheumatology) guidelines.
- Currently taking, or chronic use within 30 days of anti-inflammatory supplements, Boswellia, Curcumin, Omega-3 fatty acids, Glucosamine, Chondroitin, MSM, or Collagen supplements of any type.
- Daily use of NSAIDs (non-steroidal anti-inflammatory drugs); however, daily use of 81 mg of aspirin (not > 81 mg) for cardioprotection is allowed.
- Upon physical screening by the medical staff, any subject with signs of overt nutrient deficiencies or metabolic abnormalities such as anemia. This will also need to be included in the screening assessment.
- Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with walking or exercise testing utilized throughout the study.
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 |
|---|---|---|
| AyuFlexActive product | Dietary supplement | AyuFlex1, AyuFlex2 |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change in score from Day 0 to day 14, 42, and 84
Visual Analogue Scale scores for discomfort, mobility, disability
Time frame: Change in score from Day 0 to day 14, 42, and 84
5 secondary outcomes
Inflammatory biomarkers
Time frame: Change from Day 0 to 84
6 minute walk test
Time frame: Change in score from Day 0 to day 14, 42, and 84
Range of motion of pain-free knee flexion/extension
Time frame: Change from Day 0 to 84
Blood chemistry
Time frame: Change from Day 0 to 84
Vital signs
Time frame: Change in score from Day 0 to day 14, 42, and 84
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 18 Apr 2017.
- Derived from this study: PubMed 28969626Lopez HL, Habowski SM, Sandrock JE, Raub B, Kedia A, Bruno EJ, Ziegenfuss TN. Effects of dietary supplementation with a standardized aqueous extract of Terminalia chebula fruit (AyuFlex(R)) on joint mobility, comfort, and functional capacity in healthy overweight subjects: a randomized placebo-controlled clinical trial. BMC Complement Altern Med. 2017 Oct 2;17(1):475. doi: 10.1186/s12906-017-1977-8.
- Individual participant dataSharing planned: Undecided
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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.
Tim N Ziegenfuss, PhD principal investigator
The Center for Applied Health Sciences, LLC
Questions about this trial
What is this clinical trial studying?
A study testing AyuFlex in people with Arthralgia, run by The Center for Applied Health Sciences, LLC.
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 19 inclusion and 18 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Change in score from Day 0 to day 14, 42, and 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02589249, which also lists 1 linked publication.
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 18 Apr 2017.