The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial

NCT03106584 | Unknown DMC

• 1 other identifier: LS-17-10-Delahunt-DeVito
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test 30 individuals with mild-moderate knee joint osteoarthritis to investigate whether the combination of Aquamin (a calcium-rich marine multi-mineral) and a polyphenol-rich pine bark extract (Enzogenol), when taken as a food supplement for 3 months has comparable or superior benefits to glucosamine sulphate in patients with painful knee osteoarthritis (KOA). From here on in we refer to Aquamin's combination product as Aquamin-plus. The main outcome measure is a reduction in pain. Provision of data that demonstrate preliminary equivalency or superiority to current, non-pharmaceutical options such as glucosamine will broaden consumer choice, and provide them with an option that is supported by science, rather than marketing alone. The hypothesis of the study is that the consumption of Aquamin-plus will have comparable effects on reducing pain in individuals with Knee Joint OA to glucosamine.

Conditions

Knee Osteoarthritis

Keywords

Knee pain; Glucosamine; WOMAC; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Self reported KOA pain

  The primary outcome measure will be an assessment of the participants' knee pain. This will be measured using the validated Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function sub-scale. This will allow for the determination of the comparability, superiority or otherwise of Aquamin-plus compared to glucosamine sulphate in improving participant's self-reported knee pain and function. Change from baseline assessed.

  Baseline, mid intervention (4 and 8 weeks) post intervention (12 weeks), post washout period (16 weeks), mid intervention (20 and 24 weeks) post intervention (28 weeks)

Secondary Outcomes (6)

• Quality of life questionnaire

  Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks)

• Knee flexor and extensor muscle strength

  Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks)

• Knee flexor and extensor muscle electrical activity

  Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks)

• Biomarkers

  Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks)

• Functional mobility

  Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks)

Study Arms (2)

Glucosamine sulphate

ACTIVE COMPARATOR

Glucosamine sulphate will be consumed as either supplement A or B (i.e. blinded) for a period of 12-weeks. Glucosamine will be taken 2 times daily with food. After 12 weeks of supplementation, participants will begin taking the alternative supplement (Aquamin-plus), after a washout period of not less than 1 month between the intervention arms of the study.

Dietary Supplement: Aquamin-Plus; Dietary Supplement: Glucosamine sulphate

Aquamin-plus

EXPERIMENTAL

Aquamin-plus will be consumed as either supplement A or B (i.e. blinded) for a period of 12-weeks. Aquamin-plus will be taken 2 times daily with food. After 12 weeks of supplementation, participants will begin taking the alternative supplement (Glucosamine sulphate), after a washout period of not less than 1 month between the intervention arms of the study.

Dietary Supplement: Aquamin-Plus; Dietary Supplement: Glucosamine sulphate

Interventions

Aquamin-Plus DIETARY_SUPPLEMENT

Aquamin (a calcium-rich marine multi-mineral) - 666.7mg magnesium hydroxide - 66.66mg pine bark - 30mg vitamin d3 - 2.5μg Dosage: 4 Capsules is equal to effective dose

Aquamin-plus; Glucosamine sulphate

Glucosamine sulphate DIETARY_SUPPLEMENT

The Glucosamine sulphate supplement contains 500mg of the active ingredient Glucosamine sulphate per serving (one capsule). Dosage: 4 Capsules is equal to effective dose

Aquamin-plus; Glucosamine sulphate

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The project will focus on patients with a diagnosis of a mild-moderate KOA (level 1-3 Kellgren and Lawrence and WOMAC in the lower two quartiles), in the target knee, (Frestedt et al., 2008) and a BMI between 20 and 30 kg/m2.

You may not qualify if:

• \[1\] rheumatoid arthritis \[2\] gout \[3\] pseudo gout \[4\] Paget's disease \[5\] seizure disorder \[6\] insulin dependent diabetes mellitus \[7\] uncontrolled hypertension \[8\] unstable cardiovascular disease \[9\] active hepatic or renal disease \[10\] active cancer and/or HIV infection, involved in other clinical trial or experimental treatments in the past 3 months; pregnant, lactating, or at risk of becoming pregnant; intramuscular/systemic corticosteroid injection within 4 weeks; intra-articular corticosteroid injection within 2 months; or inter-articular hyaluronic acid injection within 4 months prior to enrollment.

Sponsors & Collaborators

• University College Dublin: lead
• Marigot Ltd.: collaborator

Study Sites (1)

Institue for Sport and Health UCD

Dublin, Leinster, D04 V1W8, Ireland

Location

Related Publications (37)

• Frestedt JL, Walsh M, Kuskowski MA, Zenk JL. A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial. Nutr J. 2008 Feb 17;7:9. doi: 10.1186/1475-2891-7-9.

  PMID: 18279523 BACKGROUND

• Frestedt JL, Kuskowski MA, Zenk JL. A natural seaweed derived mineral supplement (Aquamin F) for knee osteoarthritis: a randomised, placebo controlled pilot study. Nutr J. 2009 Feb 2;8:7. doi: 10.1186/1475-2891-8-7.

  PMID: 19187557 BACKGROUND

• Murphy, C. T., et al.

  BACKGROUND

• Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.

  PMID: 25865392 BACKGROUND

• Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, Hochberg MC. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May;19(5):478-82. doi: 10.1016/j.joca.2010.09.013. Epub 2011 Mar 23.

  PMID: 21396464 BACKGROUND

• Pena Ayala AH, Fernandez-Lopez JC. [Prevalence and risk factors in osteoarthritis]. Reumatol Clin. 2007 Oct;3 Suppl 3:S6-S12. doi: 10.1016/S1699-258X(07)73648-3. Epub 2008 Nov 13. Spanish.

  PMID: 21794484 BACKGROUND

• Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.

  PMID: 18759314 BACKGROUND

• Haq SA, Davatchi F. Osteoarthritis of the knees in the COPCORD world. Int J Rheum Dis. 2011 May;14(2):122-9. doi: 10.1111/j.1756-185X.2011.01615.x.

  PMID: 21518310 BACKGROUND

• Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

  PMID: 18163497 BACKGROUND

• Carmona L, Ballina J, Gabriel R, Laffon A; EPISER Study Group. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey. Ann Rheum Dis. 2001 Nov;60(11):1040-5. doi: 10.1136/ard.60.11.1040.

  PMID: 11602475 BACKGROUND

• Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27.

  PMID: 21622766 BACKGROUND

• Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014 Jul;10(7):437-41. doi: 10.1038/nrrheum.2014.44. Epub 2014 Mar 25.

  PMID: 24662640 BACKGROUND

• Kopec JA, Richardson CG, Llewellyn-Thomas H, Klinkhoff A, Carswell A, Chalmers A. Probabilistic threshold technique showed that patients' preferences for specific trade-offs between pain relief and each side effect of treatment in osteoarthritis varied. J Clin Epidemiol. 2007 Sep;60(9):929-38. doi: 10.1016/j.jclinepi.2007.01.001. Epub 2007 May 8.

  PMID: 17689809 BACKGROUND

• Magnusson K, Scurrah K, Ystrom E, Orstavik RE, Nilsen T, Steingrimsdottir OA, Ferreira P, Fenstad AM, Furnes O, Hagen KB. Genetic factors contribute more to hip than knee surgery due to osteoarthritis - a population-based twin registry study of joint arthroplasty. Osteoarthritis Cartilage. 2017 Jun;25(6):878-884. doi: 10.1016/j.joca.2016.12.015. Epub 2016 Dec 13.

  PMID: 27986619 BACKGROUND

• Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.

  PMID: 24880830 BACKGROUND

• French HP, Galvin R, Horgan NF, Kenny RA. Prevalence and burden of osteoarthritis amongst older people in Ireland: findings from The Irish LongituDinal Study on Ageing (TILDA). Eur J Public Health. 2016 Feb;26(1):192-8. doi: 10.1093/eurpub/ckv109. Epub 2015 Jun 23.

  PMID: 26105959 BACKGROUND

• Murphy LB, Helmick CG, Schwartz TA, Renner JB, Tudor G, Koch GG, Dragomir AD, Kalsbeek WD, Luta G, Jordan JM. One in four people may develop symptomatic hip osteoarthritis in his or her lifetime. Osteoarthritis Cartilage. 2010 Nov;18(11):1372-9. doi: 10.1016/j.joca.2010.08.005. Epub 2010 Aug 14.

  PMID: 20713163 BACKGROUND

• Blalock D, Miller A, Tilley M, Wang J. Joint instability and osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2015 Feb 19;8:15-23. doi: 10.4137/CMAMD.S22147. eCollection 2015.

  PMID: 25741184 BACKGROUND

• Reginster JY, Cooper C, Bruyere O. Re: Kucharz EJ, Kovalenko V, Szanto S, et al. A review of glucosamine for knee osteoarthritis: why patented crystalline glucosamine sulfate should be differentiated from other glucosamines to maximize clinical outcomes. Curr Med Res Opin 2016;32:997-1004. Curr Med Res Opin. 2016 Nov;32(11):1771-1772. doi: 10.1080/03007995.2016.1239575. Epub 2016 Sep 29. No abstract available.

  PMID: 27649741 BACKGROUND

• Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2013;16(5):821-47. doi: 10.18433/j3vw2f.

  PMID: 24393558 BACKGROUND

• Richy F, Bruyere O, Ethgen O, Cucherat M, Henrotin Y, Reginster JY. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Arch Intern Med. 2003 Jul 14;163(13):1514-22. doi: 10.1001/archinte.163.13.1514.

  PMID: 12860572 BACKGROUND

• McAlindon TE, LaValley MP, Gulin JP, Felson DT. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis. JAMA. 2000 Mar 15;283(11):1469-75. doi: 10.1001/jama.283.11.1469.

  PMID: 10732937 BACKGROUND

• Lee YH, Woo JH, Choi SJ, Ji JD, Song GG. Effect of glucosamine or chondroitin sulfate on the osteoarthritis progression: a meta-analysis. Rheumatol Int. 2010 Jan;30(3):357-63. doi: 10.1007/s00296-009-0969-5. Epub 2009 Jun 21.

  PMID: 19544061 BACKGROUND

• Wandel S, Juni P, Tendal B, Nuesch E, Villiger PM, Welton NJ, Reichenbach S, Trelle S. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ. 2010 Sep 16;341:c4675. doi: 10.1136/bmj.c4675.

  PMID: 20847017 BACKGROUND

• Murphy LB, Moss S, Do BT, Helmick CG, Schwartz TA, Barbour KE, Renner J, Kalsbeek W, Jordan JM. Annual Incidence of Knee Symptoms and Four Knee Osteoarthritis Outcomes in the Johnston County Osteoarthritis Project. Arthritis Care Res (Hoboken). 2016 Jan;68(1):55-65. doi: 10.1002/acr.22641.

  PMID: 26097226 BACKGROUND

• Kongtharvonskul J, Anothaisintawee T, McEvoy M, Attia J, Woratanarat P, Thakkinstian A. Efficacy and safety of glucosamine, diacerein, and NSAIDs in osteoarthritis knee: a systematic review and network meta-analysis. Eur J Med Res. 2015 Mar 13;20(1):24. doi: 10.1186/s40001-015-0115-7.

  PMID: 25889669 BACKGROUND

• Prieto-Alhambra D, Judge A, Javaid MK, Cooper C, Diez-Perez A, Arden NK. Incidence and risk factors for clinically diagnosed knee, hip and hand osteoarthritis: influences of age, gender and osteoarthritis affecting other joints. Ann Rheum Dis. 2014 Sep;73(9):1659-64. doi: 10.1136/annrheumdis-2013-203355. Epub 2013 Jun 6.

  PMID: 23744977 BACKGROUND

• Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995 Aug;38(8):1134-41. doi: 10.1002/art.1780380817.

  PMID: 7639811 BACKGROUND

• Neogi T, Zhang Y. Epidemiology of osteoarthritis. Rheum Dis Clin North Am. 2013 Feb;39(1):1-19. doi: 10.1016/j.rdc.2012.10.004. Epub 2012 Nov 10.

  PMID: 23312408 BACKGROUND

• Gabriel SE, Michaud K. Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases. Arthritis Res Ther. 2009;11(3):229. doi: 10.1186/ar2669. Epub 2009 May 19.

  PMID: 19519924 BACKGROUND

• Irvine, James Colquhoun, David McNicoll, and Alexander Hynd.

  BACKGROUND

• MacGregor AJ, Antoniades L, Matson M, Andrew T, Spector TD. The genetic contribution to radiographic hip osteoarthritis in women: results of a classic twin study. Arthritis Rheum. 2000 Nov;43(11):2410-6. doi: 10.1002/1529-0131(200011)43:113.0.CO;2-E.

  PMID: 11083262 BACKGROUND

• Spector TD, Cicuttini F, Baker J, Loughlin J, Hart D. Genetic influences on osteoarthritis in women: a twin study. BMJ. 1996 Apr 13;312(7036):940-3. doi: 10.1136/bmj.312.7036.940.

  PMID: 8616305 BACKGROUND

• MacGregor AJ, Li Q, Spector TD, Williams FM. The genetic influence on radiographic osteoarthritis is site specific at the hand, hip and knee. Rheumatology (Oxford). 2009 Mar;48(3):277-80. doi: 10.1093/rheumatology/ken475. Epub 2009 Jan 19.

  PMID: 19153142 BACKGROUND

• Skousgaard SG, Skytthe A, Moller S, Overgaard S, Brandt LP. Sex differences in risk and heritability estimates on primary knee osteoarthritis leading to total knee arthroplasty: a nationwide population based follow up study in Danish twins. Arthritis Res Ther. 2016 Feb 11;18:46. doi: 10.1186/s13075-016-0939-8.

  PMID: 26864139 BACKGROUND

• Skousgaard SG, Hjelmborg J, Skytthe A, Brandt LP, Moller S, Overgaard S. Probability and heritability estimates on primary osteoarthritis of the hip leading to total hip arthroplasty: a nationwide population based follow-up study in Danish twins. Arthritis Res Ther. 2015 Nov 20;17:336. doi: 10.1186/s13075-015-0854-4.

  PMID: 26589897 BACKGROUND

• Heffernan SM, McCarthy C, Eustace S, FitzPatrick RE, Delahunt E, De Vito G. Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial. Complement Ther Med. 2020 May;50:102349. doi: 10.1016/j.ctim.2020.102349. Epub 2020 Feb 19.

  PMID: 32444040 DERIVED

Related Links

• Algae-based food supplement PATENT
• Method of preparing a novel antacid pharmaceutical product PATENT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Giuseppe De Vito, Prof.

  UCD

  STUDY CHAIR

• Eamonn Delahunt, PhD

  UCD

  PRINCIPAL INVESTIGATOR

• Conor McCarthy, MD

  Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shane M Heffernan, Phd

CONTACT

00353 1 716 3433; shane.heffernan@ucd.ie

Mark McGroarty, MSc

CONTACT

00353 86 083 0034; mark.mcgroarty@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The supplements provided by Marigot Ltd. will be marked either A or B. No member of the research team will be aware of the ingredients in either of the supplements, the only distinguishing feature will be the labels - A and B. It is for this reason that we can say that the study will be double blind as neither investigators nor participants will have any knowledge of the supplement that they will be consuming.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The project is a double blind randomized controlled clinical trial (pilot), with a cross-over design. Participants, will be randomized to begin taking either Aquamin-plus or Glucosamine sulphate following medical diagnosis and baseline assessment. Following 12 weeks of supplementation of Glucosamine sulphate or Aquamin-plus there will be a 4-week washout period before participants consume the other supplement.

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 10, 2017
• Study Start: May 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: October 1, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)