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

Orthomedico

Status: Completed

Conditions: Healthy Japanese Subjects

Treatments: Dietary Supplement: UltraHA® 40 mg/capsule; Dietary Supplement: Placebo; Dietary Supplement: UltraHA® 75 mg/capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05683327

06793-0003-0E

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

66 participants in 3 patient groups, including a placebo group

Hyaluronic Acid 150 mg

Active Comparator group

Description:

Take 150 mg/day of hyaluronic acid.

Treatment:

Dietary Supplement: UltraHA® 75 mg/capsule

Hyaluronic Acid 80 mg

Active Comparator group

Description:

Take 80 mg/day of hyaluronic acid.

Treatment:

Dietary Supplement: UltraHA® 40 mg/capsule

Placebo

Placebo Comparator group

Description:

Take 0 mg/day of hyaluronic acid.

Treatment:

Dietary Supplement: Placebo