Does oral creatine supplementation enhance recovery from a worsening of chronic bronchitis?
ISRCTN | ISRCTN22287730 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN22287730 |
Secondary identifying numbers | RN06NT003 |
- 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
Scientific
Dept. of Human Nutrition
University of Glasgow
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
Study information
Study design | Randomised stratified double-blind placebo-controlled study |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Does oral creatine supplementation enhance recovery from chronic obstructive pulmonary disease (COPD) exacerbation? |
Study objectives | 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(s) | Glasgow East LREC, 24/08/2006, ref: 06/50704/45 |
Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
Intervention | 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 | Supplement |
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 study start date | 29/05/2007 |
Completion date | 29/05/2008 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 60 |
Key inclusion criteria | 1. Chronic obstructive pulmonary disease (COPD) 2. Acute exacerbation COPD |
Key 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 |
Date of first enrolment | 29/05/2007 |
Date of final enrolment | 29/05/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University of Glasgow
Glasgow
G31 2ER
United Kingdom
G31 2ER
United Kingdom
Sponsor information
University of Glasgow (UK)
University/education
University/education
Research and Enterprise
University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom
Website | http://www.gla.ac.uk/ |
---|---|
https://ror.org/00vtgdb53 |
Funders
Funder type
Government
Chief Scientist Office (UK) (ref: CZG/2/261)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Glasgow Royal Infirmary (UK) - Endowment Fund (ref: 06Ref004 CH02 - Mullan)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Thesis results | results | 07/01/2013 | No | No |
Editorial Notes
08/06/2017: Publication reference added.