Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
23/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr T Ispoglou

ORCID ID

Contact details

School of leisure and sports studies
Calverley Street
Leeds
LS1 3HE
United Kingdom
+44 (0)113 2832600

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436146689

Study information

Scientific title

Acronym

Study hypothesis

To investigate whether long-term leucine supplementation in combination with resistance training can induce higher increases in strength and muscle mass of untrained subjects compared to a placebo group undertaking resistance training only.
To investigate potential decreases in muscle mass after four weeks following the end of the supplementation period

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Leucine supplementation

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Bone density

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2003

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male subjects

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

30 male volunteers

Participant exclusion criteria

1. Athletes or trained subjects
2. Having diabetes
3. Heart disease
4. High blood pressure or any other chronic or serious illness
5. Having taken anabolic steroids or any other sports supplements at least 2 months before the beginning of the study

Recruitment start date

01/12/2003

Recruitment end date

01/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of leisure and sports studies
Leeds
LS1 3HE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21487148

Publication citations

  1. Results

    Ispoglou T, King RF, Polman RC, Zanker C, Daily L-leucine supplementation in novice trainees during a 12-week weight training program., Int J Sports Physiol Perform, 2011, 6, 1, 38-50.

Additional files

Editorial Notes