Does oral creatine supplementation enhance recovery from a worsening of chronic bronchitis?

ISRCTN ISRCTN22287730
DOI https://doi.org/10.1186/ISRCTN22287730
Protocol serial number RN06NT003
Sponsor University of Glasgow (UK)
Funders Chief Scientist Office (UK) (ref: CZG/2/261), Glasgow Royal Infirmary (UK) - Endowment Fund (ref: 06Ref004 CH02 - Mullan)
Submission date
03/08/2007
Registration date
19/03/2008
Last edited
08/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Lean
Scientific

Dept. of Human Nutrition
University of Glasgow
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom

Study information

Primary study designInterventional
Study designRandomised stratified double-blind placebo-controlled study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleDoes oral creatine supplementation enhance recovery from chronic obstructive pulmonary disease (COPD) exacerbation?
Study objectivesIn patients with chronic obstructive pulmonary disease (COPD) exacerbation, supplementation with 5 g of creatine monohydrate three times daily prevents loss of, or increases, fat free mass after 14 days of treatment when compared to placebo.
Ethics approval(s)Glasgow East LREC, 24/08/2006, ref: 06/50704/45
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD)
InterventionThe study will have two arms:

1. Standard care with placebo:
This will comprise best clinical practice defined by National Institute for Clinical Excellence (NICE) (Clinical Guideline 12: "Management of chronic obstructive pulmonary disease in adults in primary and secondary care." February 2004). Placebo consists of 5 g lactose mixed with 30 g glucose monohydrate, given mixed with hot water as a drink, three times a day.

2. Standard care with creatine:
This will comprise best clinical practice defined by NICE (Clinical Guideline 12: "Management of chronic obstructive pulmonary disease in adults in primary and secondary care." February 2004). Creatine supplementation is given as 5 g of creatine monohydrate mixed with 30 g glucose monohydrate, given mixed with hot water as a drink, three times a day. There is evidence that concomitant administration of glucose increases muscle uptake of creatine.

Patients will receive the investigational supplement for 14 days (42 doses).

Details of investigational supplement:
Creatine is naturally found in the body and is present in the diet in fish and meat (herring contains 6.5 - 10 g creatine per kg). Approximately 50% of total body creatine is provided by the diet with the rest produced endogenously from the amino acids arginine, glycine and methionine in the liver and kidneys. The majority of body creatine is stored in skeletal muscle, where the creatine transporter protein moves creatine across the plasma membrane from the blood against a large concentration gradient. Creatine spontaneously degrades to creatinine, which is excreted by the kidneys. Creatine is rapidly phosphorylated to phosphocreatine which provides essential energy to exercising muscle via re-phosphorylation of adenosine diphosphate (ADP) to adenosine triphosphate (ATP).
Intervention typeSupplement
Primary outcome measure(s)

Fat free mass, measured at baseline and after treatment (2/52; or 42 doses)

Key secondary outcome measure(s)

1. Anthropometry
2. Hand-grip and strength
3. Maximal expiratory pressure (MEP)/maximal inspiratory pressure (MIP)/sniff nasal inspiratory pressure (SNIP)
4. Rise to go test
5. Six minute walk test (SMWT)
6. High sensitivity C-reactive protein (hsCRP)
7. Interleukin-six (IL-6)
8. Tumour necrosis factor-alpha (TNF-α)
9. Digit span
10. Medical Research Council (MRC) dyspnoea scale
11. Hospital Anxiety and Depression (HAD) score
12. London Chest Activity of Daily Living (LCADL) score
13. Baseline/Transition Dyspnoea Index (BDI/TDI)

All endpoints measured at baseline and after treatment (2/52; or 42 doses)

Completion date29/05/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration60
Key inclusion criteria1. Chronic obstructive pulmonary disease (COPD)
2. Acute exacerbation COPD
Key exclusion criteria1. Alternative diagnosis for acute presentation
2. Active cardiac, neurological, neoplastic disease
3. Diabetes
4. Significant locomotor disease
5. Renal or hepatic impairment
6. Persisting decompensated respiratory acidosis
7. Depressed cognitive function
8. Terminal condition
9. Pregnant, lactating, or wish to become pregnant
10. Implanted cardiac pacemaker resynchronise or defibrillator device
11. Enteral route contraindicated
Date of first enrolment29/05/2007
Date of final enrolment29/05/2008

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

University of Glasgow
Glasgow
G31 2ER
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Thesis results results 07/01/2013 No No

Editorial Notes

08/06/2017: Publication reference added.

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