The Effect of AyuFlex® Supplementation on Joint Health

NCT02589249 | Completed DMC

• 1 other identifier: NATAF-001-2015
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Arthralgia

Outcome Measures

Primary Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Change in score from Day 0 to day 14, 42, and 84

• Visual Analogue Scale scores for discomfort, mobility, disability

  Change in score from Day 0 to day 14, 42, and 84

Secondary Outcomes (5)

• Inflammatory biomarkers

  Change from Day 0 to 84

• 6 minute walk test

  Change in score from Day 0 to day 14, 42, and 84

• Range of motion of pain-free knee flexion/extension

  Change from Day 0 to 84

• Blood chemistry

  Change from Day 0 to 84

• Vital signs

  Change in score from Day 0 to day 14, 42, and 84

Study Arms (3)

Placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

AyuFlex1

ACTIVE COMPARATOR

AyuFlex1 (500 mg/d)

Dietary Supplement: AyuFlex

AyuFlex2

ACTIVE COMPARATOR

AyuFlex2 (1000 mg/d)

Dietary Supplement: AyuFlex

Interventions

AyuFlex DIETARY_SUPPLEMENT

Active product

AyuFlex1; AyuFlex2

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead
• Natreon, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 28969626 DERIVED

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim N Ziegenfuss, PhD

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2015
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04