Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Michael Lean


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Does oral creatine supplementation enhance recovery from chronic obstructive pulmonary disease (COPD) exacerbation?


Study hypothesis

In 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

Glasgow East LREC, 24/08/2006, ref: 06/50704/45

Study design

Randomised stratified double-blind placebo-controlled study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Chronic obstructive pulmonary disease (COPD)


The 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 type



Not Specified

Drug names

Creatine supplementation

Primary outcome measure

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

Secondary outcome measures

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)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Chronic obstructive pulmonary disease (COPD)
2. Acute exacerbation COPD

Participant type


Age group

Not Specified


Not Specified

Target number of participants


Participant exclusion criteria

1. 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
G31 2ER
United Kingdom

Sponsor information


University of Glasgow (UK)

Sponsor details

Research and Enterprise
University Avenue
G12 8QQ
United Kingdom

Sponsor type




Funder type


Funder name

Chief Scientist Office (UK) (ref: CZG/2/261)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

government non-federal


United Kingdom

Funder name

Glasgow Royal Infirmary (UK) - Endowment Fund (ref: 06Ref004 CH02 - Mullan)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2013 results in:

Publication citations

Additional files

Editorial Notes

08/06/2017: Publication reference added.