NCT01767844

Brief Summary

Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly. 50 participants will be given a food supplement to take for 12 weeks; this supplement will either be creatine or a placebo (a regular fruit flavoured powder that has no benefits). Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will be tested. In addition, quality of life questionnaires will be completed, disease activity will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be obtained, from those who volunteer to provide them, at baseline and post-treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

January 8, 2013

Last Update Submit

December 2, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisArthritisRheumatologyCreatine

Outcome Measures

Primary Outcomes (1)

  • Change in 'Objectively assessed whole body function'

    Physical function will be assessed using the following tests: 1. strength tests of the knee muscles and hand-grip 2. the Up-and-Go Test (UG) - For the UG, participants are required rise from a seated position on a fixed chair, walk forward to a cone placed 8ft (2.44 m) away, and return to the chair and a seated position. 3. the sit-to-stand in 30 sec test (SST-30) - For the SST-30 participants will rise from the same seated position as during the UG as many times as possible in 30 s whilst keeping their arms folded across the chest. 4. 50-ft walk test - During the 50-ft walk test, time taken to complete the walk along a straight line marked by cones is recorded 5. To assess fitness participants will complete the Siconolfi step test.

    Measured at Baseline, Day 6, Week 12, Week 24

Secondary Outcomes (1)

  • Change in body composition

    Baseline, Day 6, Week 12, Week 24

Study Arms (2)

Creatine

EXPERIMENTAL

Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.

Dietary Supplement: Creatine

Fruit powder drink

PLACEBO COMPARATOR

A regular fruit flavoured powder that has no benefits

Dietary Supplement: Placebo

Interventions

CreatineDIETARY_SUPPLEMENT

Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.

Also known as: Creatine Monohydrate (MyProtein.uk), SN: 5055534301999 BB: 09/2014
Creatine
PlaceboDIETARY_SUPPLEMENT
Also known as: Placebo Comparator: Fruit powder drink - A regular fruit flavoured powder that has no benefits., Manufactured by Foster Clarks Ltd (www.fosterclark.com)
Fruit powder drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fulfil the American Rheumatism Association 1987 revised criteria for the diagnosis of RA
  • be functional class I or II
  • be age 18 years or over

You may not qualify if:

  • be cognitively impaired; (b) have any other cachectic diseases and any condition preventing safe participation in the study
  • have a glomerular filtration rate above 60mL/min/1.73m2, assessed from medical records, and no other evidence of kidney damage
  • be taking drugs or other nutritional supplements known to increase muscle mass
  • be participating in regular and intense physical training program be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangor University

Bangor, Gwynedd, LL572PZ, United Kingdom

Location

Related Publications (7)

  • Willer B, Stucki G, Hoppeler H, Bruhlmann P, Krahenbuhl S. Effects of creatine supplementation on muscle weakness in patients with rheumatoid arthritis. Rheumatology (Oxford). 2000 Mar;39(3):293-8. doi: 10.1093/rheumatology/39.3.293.

    PMID: 10788538BACKGROUND

  • Lemmey AB, Jones J, Maddison PJ. Rheumatoid cachexia: what is it and why is it important? J Rheumatol. 2011 Sep;38(9):2074; author reply 2075. doi: 10.3899/jrheum.110308. No abstract available.

    PMID: 21885521BACKGROUND

  • Lemmey AB, Williams SL, Marcora SM, Jones J, Maddison PJ. Are the benefits of a high-intensity progressive resistance training program sustained in rheumatoid arthritis patients? A 3-year followup study. Arthritis Care Res (Hoboken). 2012 Jan;64(1):71-5. doi: 10.1002/acr.20523.

    PMID: 21671413BACKGROUND

  • Lemmey AB, Marcora SM, Chester K, Wilson S, Casanova F, Maddison PJ. Effects of high-intensity resistance training in patients with rheumatoid arthritis: a randomized controlled trial. Arthritis Rheum. 2009 Dec 15;61(12):1726-34. doi: 10.1002/art.24891.

    PMID: 19950325BACKGROUND

  • Marcora S, Lemmey A, Maddison P. Dietary treatment of rheumatoid cachexia with beta-hydroxy-beta-methylbutyrate, glutamine and arginine: a randomised controlled trial. Clin Nutr. 2005 Jun;24(3):442-54. doi: 10.1016/j.clnu.2005.01.006. Epub 2005 Apr 21.

    PMID: 15896432BACKGROUND

  • Cooney JK, Law RJ, Matschke V, Lemmey AB, Moore JP, Ahmad Y, Jones JG, Maddison P, Thom JM. Benefits of exercise in rheumatoid arthritis. J Aging Res. 2011 Feb 13;2011:681640. doi: 10.4061/2011/681640.

    PMID: 21403833BACKGROUND

  • Nissen SL, Sharp RL. Effect of dietary supplements on lean mass and strength gains with resistance exercise: a meta-analysis. J Appl Physiol (1985). 2003 Feb;94(2):651-9. doi: 10.1152/japplphysiol.00755.2002. Epub 2002 Oct 25.

    PMID: 12433852BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

Creatine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Andrew B Lemmey, Prof.

    Bangor University

    PRINCIPAL INVESTIGATOR

  • Thomas O'Brien, Dr

    Bangor University

    PRINCIPAL INVESTIGATOR

  • Thomas J Wilkinson

    Bangor Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Research Student

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 14, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

GB(1)