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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Japanese Subjects
• Intervention / Treatment: Dietary supplement: UltraHA® 75 mg/capsule; Dietary supplement: UltraHA® 40 mg/capsule; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Nerima-ku, Tokyo, Japan, 176-0002
      • Nerima Medical Association Minami-machi Clinic
    • Shinagawa-Ku, Tokyo, Japan, 141-0022
      • Medical Corporation Seishinkai, Takara Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose skin viscoelasticity is relatively low at screening (before consumption)
6. Subjects whose BMI are 23 kg/m^2 or more and less than 30 kg/m^2
7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray
8. Subjects whose WOMAC score is relatively high

Exclusion Criteria:

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. 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
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate
6. Subjects who are currently taking medications (including herbal medicines) and supplements
7. Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol)
8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
9. Subjects who suffer from COVID-19
10. 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
11. Subjects who are judged as ineligible to participate in this study by the physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyaluronic Acid 150 mg; Take 150 mg/day of hyaluronic acid.	Dietary supplement: UltraHA® 75 mg/capsule; Take 2 capsules per day at any time.
Active Comparator: Hyaluronic Acid 80 mg; Take 80 mg/day of hyaluronic acid.	Dietary supplement: UltraHA® 40 mg/capsule; Take 2 capsules per day at any time.
Placebo Comparator: Placebo; Take 0 mg/day of hyaluronic acid.	Dietary supplement: Placebo; Take 2 capsules per day at any time.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orthomedico Inc.
• Collaborators: BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED
• Investigators: Study Chair: Tsuyoshi Takara, MD, Medical Corporation Seishinkai, Takara Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Actual): June 24, 2023
• Study Completion (Actual): June 24, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Knee; Hyaluronic Acid
• Other Study ID Numbers: 06793-0003-0E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be discussed among the research affiliates after the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No