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The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial

NCT03106584 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Marigot Ltd.

    collaborator INDUSTRY

  • University College Dublin

    lead OTHER

Principal Investigators

  • Giuseppe De Vito, Prof. · UCD

  • Eamonn Delahunt, PhD · UCD

  • Conor McCarthy, MD · Mater Misericordiae University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-08-31
Completion
2017-10-01

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106584 on ClinicalTrials.gov