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The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial (MOANi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106584
Recruitment Status : Unknown
Verified April 2017 by University College Dublin.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Marigot Ltd.
Information provided by (Responsible Party):
University College Dublin

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: Aquamin-Plus Dietary Supplement: Glucosamine sulphate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Investigating the Potential for Marigot's Nutrition Supplement to Improve Symptoms and Physical Function in Those With Mild to Moderate Knee Osteoarthritis (KOA) Versus the Current Market Leader (Glucosamine Sulphate)
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : August 31, 2017
Estimated Study Completion Date : October 1, 2017


Arm Intervention/treatment
Active Comparator: Glucosamine sulphate

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

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


Dietary Supplement: Glucosamine sulphate

The Glucosamine sulphate supplement contains 500mg of the active ingredient Glucosamine sulphate per serving (one capsule).

Dosage:

4 Capsules is equal to effective dose


Experimental: Aquamin-plus

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

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


Dietary Supplement: Glucosamine sulphate

The Glucosamine sulphate supplement contains 500mg of the active ingredient Glucosamine sulphate per serving (one capsule).

Dosage:

4 Capsules is equal to effective dose





Primary Outcome Measures :
  1. Self reported KOA pain [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks) ]
    This will be quantified by the EuroQoL-5D. The EuroQoL-5D will assess participants on their levels of function surrounding mobility, self-care, usual activities, pain / discomfort, anxiety / depression. Change from baseline assessed.

  2. Knee flexor and extensor muscle strength [ Time Frame: Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks) ]
    Participants knee joint strength will be assessed using an isokinetic dynamometer (Cybex). Specifically isometric strength of the quadricep and hamstring muscles. Change from baseline assessed.

  3. Knee flexor and extensor muscle electrical activity [ Time Frame: Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks) ]
    Muscles activation (via electromyography) during the performance of the isometric testing will be assessed for the quadricep and hamstring muscles. Both the agonist and antagonist muscle activity will be assessed and a co-contraction value will be calculated. Change from baseline assessed.

  4. Biomarkers [ Time Frame: Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks) ]
    Biomarkers known to be involved in the biological response to KOA will be assessed to investigate possible mechanistic effects and differences of both interventions. As such, in order to investigate these possible mechanistic parameters include venous blood sampling (10 mL). Change from baseline assessed.

  5. Functional mobility [ Time Frame: Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks) ]
    This will be assessed using the Six-minute Walk Test (6MWT) and the Timed Up and Go Test (TUG). These tests indicate levels of functional. Change from baseline assessed.

  6. Body Composition [ Time Frame: Participants will be assessed on 4 separate occasions: Baseline, post intervention (12 weeks), post washout period (16 weeks), post intervention (28 weeks) ]
    A Dule-Energy X ray Absorptimetry (DEXA) will be used to assess participants body composition. Change from baseline assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

[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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106584


Contacts
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Contact: Shane M Heffernan, Phd 00353 1 716 3433 shane.heffernan@ucd.ie
Contact: Mark McGroarty, MSc 00353 86 083 0034 mark.mcgroarty@ucd.ie

Locations
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Ireland
Institue for Sport and Health UCD
Dublin, Leinster, Ireland, D04 V1W8
Contact: Shane Heffernan, PhD    00353 1 716 3433 ext 3433    shane.heffernan@ucd.ie   
Contact: Mark McGroarty, MSc    00353 86 0830034    mark.mcgroarty@ucd.ie   
Sponsors and Collaborators
University College Dublin
Marigot Ltd.
Investigators
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Study Chair: Giuseppe De Vito, Prof. UCD
Principal Investigator: Eamonn Delahunt, PhD UCD
Principal Investigator: Conor McCarthy, MD Mater Misericordiae University Hospital
Additional Information:
Publications:
Murphy, C. T., et al.
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. Erratum in: Lancet. 2014 Aug 30;384(9945):746.
Irvine, James Colquhoun, David McNicoll, and Alexander Hynd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT03106584    
Other Study ID Numbers: LS-17-10-Delahunt-DeVito
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College Dublin:
Knee pain
Glucosamine
WOMAC
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases