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

Not Applicable

Completed

• Conditions: Healthy Japanese Subjects
• Interventions: Dietary Supplement: UltraHA® 75 mg/capsule; Dietary Supplement: Placebo; Dietary Supplement: UltraHA® 40 mg/capsule

• Registration Number: NCT05683327
• Lead Sponsor: Orthomedico Inc.

Brief Summary

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

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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Study Start: 2023-01-06
• Study First Posted: 2023-01-13
• Primary Completion: 2023-06-24
• Study Completion: 2023-06-24
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid 150 mg	UltraHA® 75 mg/capsule	Take 150 mg/day of hyaluronic acid.
Placebo	Placebo	Take 0 mg/day of hyaluronic acid.
Hyaluronic Acid 80 mg	UltraHA® 40 mg/capsule	Take 80 mg/day of hyaluronic acid.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Each WOMAC subscale score at Week 12	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.
Subjective symptoms at Week 12	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.

Trial Locations

Locations (2)

Nerima Medical Association Minami-machi Clinic; 🇯🇵 Nerima-ku, Tokyo, Japan

Medical Corporation Seishinkai, Takara Clinic; 🇯🇵 Shinagawa-Ku, Tokyo, Japan