The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function

Study Overview
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Brief Summary
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This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.

Detailed Description
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In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.

Official Title
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The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study

Conditions
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Healthy Japanese Subjects

Intervention / Treatment
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* Dietary Supplement: UltraHA® 75 mg/capsule
* Dietary Supplement: UltraHA® 40 mg/capsule
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese Men or women Adults Healthy subjects Subjects whose skin viscoelasticity is relatively low at screening (before consumption) Subjects whose BMI are 23 kg/m^2 or more and less than 30 kg/m^2 Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray Subjects whose WOMAC score is relatively high Exclusion Criteria: Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases Subjects who use or take Foods for Specified Health Uses, or Foods with Functional Claims in daily Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate Subjects who are currently taking medications (including herbal medicines) and supplements Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol) Subjects who are pregnant, lactating, or planning to become pregnant during this trial Subjects who suffer from COVID-19 Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial Subjects who are judged as ineligible to participate in this study by the physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic Acid 150 mg<br>Take 150 mg/day of hyaluronic acid. | Dietary Supplement: UltraHA® 75 mg/capsule<br>* Take 2 capsules per day at any time.<br>|
| Active Comparator: Hyaluronic Acid 80 mg<br>Take 80 mg/day of hyaluronic acid. | Dietary Supplement: UltraHA® 40 mg/capsule<br>* Take 2 capsules per day at any time.<br>|
| Placebo Comparator: Placebo<br>Take 0 mg/day of hyaluronic acid. | Dietary Supplement: Placebo<br>* Take 2 capsules per day at any time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12 | The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of responses is evaluated as the WOMAC scores. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each WOMAC subscale score at Week 12 | The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of each subscale response is evaluated as the WOMAC subscale score. | Week 12 | 
| Subjective symptoms at Week 12 | Assess knee pain, stiffness, discomfort, and health using visual analogue scale. There is a 100 mm straight line with the best and worst degree of sensation indicated at both ends, and the current degree of sensation is marked on the line with the best imaginable state being 0 and the worst state being 100. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, Knee