Contact information
Type
Scientific
Primary contact
Dr Bruce Griffin
ORCID ID
Contact details
School of Biomedical & Molecular Sciences
University of Surrey
Guildford
GU2 7XH
United Kingdom
+44 (0)1483879724
b.griffin@surrey.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
1. Consumption of 2 eggs per day for 12 weeks will produce no significant effect on plasma cholesterol and other related biomarkers of CHD risk when accompanied by weight-loss induced by an energy-restricted diet
2. That egg consumption will promote greater weight-loss with an energy-restricted diet than an energy-restricted diet alone
Ethics approval
Ethics committee (ref: EC/2004/109/SBMS)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Overweight
Intervention
Test group: 2 small eggs/day + energy-restricted diet (~500 Kcal/day following British Heart Foundation [BHF] guidelines).
Control group: energy-restricted diet alone.
12 week intervention.
Intervention type
Drug
Phase
Not Specified
Drug names
Eggs
Primary outcome measures
1. Total plasma cholesterol
2. Low-density lipoprotein (LDL) cholesterol
3. Body weight
Secondary outcome measures
Plasma cholesterol precursors (mevalonate and lathosterol) and plant sterols (beta-sitosterol and campesterol) as markers of cholesterol synthesis and absorption respectively
Overall trial start date
01/05/2005
Overall trial end date
01/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy adult male and females aged 18-55 years
2. Body Mass Index (BMI) that classifies them as being overweight >25, <40
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. BMI >40 (morbid obesity)
2. Total plasma cholesterol >6.5 mM
3. No prescribed medication
4. No dietary supplements including 'cholesterol-lowering' foods (e.g. benecol or flora proactive) or existing diets or having lost >3 kg in preceding 2 months
Recruitment start date
01/05/2005
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Biomedical & Molecular Sciences
Guildford
GU2 7XH
United Kingdom
Sponsor information
Organisation
British Egg Information Service (UK)
Sponsor details
126-128 Cromwell Road
London
SW7 4ET
United Kingdom
+44 (0)20 7370 7411
info@britegg.co.uk
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
British Egg Information Service (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Surrey (UK) - Finance Office, RC4022
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18726564
Publication citations
-
Results
Harman NL, Leeds AR, Griffin BA, Increased dietary cholesterol does not increase plasma low density lipoprotein when accompanied by an energy-restricted diet and weight loss., Eur J Nutr, 2008, 47, 6, 287-293, doi: 10.1007/s00394-008-0730-y.