A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis

Osteoarthritis is a significant global health problem. Many patients seek more effective alternatives to nonsteroidal anti-inflammatory medicines or commercial supplements to manage joint pain and inflammation. FlexPro MD<sup>®</sup> (FP-MD) combines krill oil, astaxanthin, and lower mol...

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Main Authors: W. Stephen Hill, Margaret H. Dohnalek, Yejin Ha, Seok-Jung Kim, Jae-Chul Jung, Seung-Baik Kang
Format: Article
Language:English
Published: MDPI AG 2023-08-01
Series:Nutrients
Subjects:
Online Access:https://www.mdpi.com/2072-6643/15/17/3769
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author W. Stephen Hill
Margaret H. Dohnalek
Yejin Ha
Seok-Jung Kim
Jae-Chul Jung
Seung-Baik Kang
author_facet W. Stephen Hill
Margaret H. Dohnalek
Yejin Ha
Seok-Jung Kim
Jae-Chul Jung
Seung-Baik Kang
author_sort W. Stephen Hill
collection DOAJ
description Osteoarthritis is a significant global health problem. Many patients seek more effective alternatives to nonsteroidal anti-inflammatory medicines or commercial supplements to manage joint pain and inflammation. FlexPro MD<sup>®</sup> (FP-MD) combines krill oil, astaxanthin, and lower molecular weight hyaluronic acid to support joint health. A 12-week, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of FP-MD and placebo once daily in participants (n = 100) with mild osteoarthritis of the knee or hip joint. For the primary endpoint of joint pain score, per-protocol participants (n = 75) in the FP-MD group (n = 37) had a statistically significantly greater mean reduction from baseline in the Korean Visual Analog Scale (K-VAS) at week 12 compared with participants in the placebo group (n = 38) (20.8 ± 16.16 mm vs. 10.6 ± 17.58, <i>p</i> = 0.0105). The Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) total score was also significantly improved in the FP-MD group at week 12 compared with placebo (−13.0 ± 13.62 vs. −5.5 ± 18.08, <i>p</i> = 0.0489), especially an improvement in pain score (−2.5 ± 2.92 vs. −1.3 ± 3.94, <i>p</i> = 0.02635). FP-MD group had greater improvement in joint function scoring by investigator assessment (<i>p</i> = 0.0127) and by group participants (<i>p</i> = 0.0070). A statistically significantly greater number of patients reported adverse events in the placebo group compared with the FP-MD group (16% vs. 4%, <i>p</i> = 0.0455), most commonly gastrointestinal disorders in both of the groups. These findings suggest that FP-MD is well tolerated and can be effectively used to address joint pain in patients diagnosed with mild osteoarthritis, the main symptom of this condition.
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spelling doaj.art-410e1f8a871248afad1648dbfd43e30a2023-11-19T08:38:53ZengMDPI AGNutrients2072-66432023-08-011517376910.3390/nu15173769A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild OsteoarthritisW. Stephen Hill0Margaret H. Dohnalek1Yejin Ha2Seok-Jung Kim3Jae-Chul Jung4Seung-Baik Kang5US Nutraceuticals, Inc. d/b/a Valensa International, Eustis, FL 32726, USAUS Nutraceuticals, Inc. d/b/a Valensa International, Eustis, FL 32726, USANOVAREX Co., Ltd., 80, Osongsaengmyeong 14-ro, Osong-eup, Chueongju-si 28220, Republic of KoreaDepartment of Orthopedic Surgery, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Cheonbo-ro, Uijeongbu-si 11765, Republic of KoreaNOVAREX Co., Ltd., 80, Osongsaengmyeong 14-ro, Osong-eup, Chueongju-si 28220, Republic of KoreaDepartment of Orthopedic Surgery, Seoul National University College of Medicine, Boramae Hospital, Seoul 07061, Republic of KoreaOsteoarthritis is a significant global health problem. Many patients seek more effective alternatives to nonsteroidal anti-inflammatory medicines or commercial supplements to manage joint pain and inflammation. FlexPro MD<sup>®</sup> (FP-MD) combines krill oil, astaxanthin, and lower molecular weight hyaluronic acid to support joint health. A 12-week, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of FP-MD and placebo once daily in participants (n = 100) with mild osteoarthritis of the knee or hip joint. For the primary endpoint of joint pain score, per-protocol participants (n = 75) in the FP-MD group (n = 37) had a statistically significantly greater mean reduction from baseline in the Korean Visual Analog Scale (K-VAS) at week 12 compared with participants in the placebo group (n = 38) (20.8 ± 16.16 mm vs. 10.6 ± 17.58, <i>p</i> = 0.0105). The Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) total score was also significantly improved in the FP-MD group at week 12 compared with placebo (−13.0 ± 13.62 vs. −5.5 ± 18.08, <i>p</i> = 0.0489), especially an improvement in pain score (−2.5 ± 2.92 vs. −1.3 ± 3.94, <i>p</i> = 0.02635). FP-MD group had greater improvement in joint function scoring by investigator assessment (<i>p</i> = 0.0127) and by group participants (<i>p</i> = 0.0070). A statistically significantly greater number of patients reported adverse events in the placebo group compared with the FP-MD group (16% vs. 4%, <i>p</i> = 0.0455), most commonly gastrointestinal disorders in both of the groups. These findings suggest that FP-MD is well tolerated and can be effectively used to address joint pain in patients diagnosed with mild osteoarthritis, the main symptom of this condition.https://www.mdpi.com/2072-6643/15/17/3769FlexPro MD<sup>®</sup>osteoarthritisinflammationjoint painkrill oilastaxanthin
spellingShingle W. Stephen Hill
Margaret H. Dohnalek
Yejin Ha
Seok-Jung Kim
Jae-Chul Jung
Seung-Baik Kang
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis
Nutrients
FlexPro MD<sup>®</sup>
osteoarthritis
inflammation
joint pain
krill oil
astaxanthin
title A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis
title_full A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis
title_fullStr A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis
title_full_unstemmed A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis
title_short A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis
title_sort multicenter randomized double blinded placebo controlled clinical trial to evaluate the efficacy and safety of a krill oil astaxanthin and oral hyaluronic acid complex on joint health in people with mild osteoarthritis
topic FlexPro MD<sup>®</sup>
osteoarthritis
inflammation
joint pain
krill oil
astaxanthin
url https://www.mdpi.com/2072-6643/15/17/3769
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