Effects of increased egg consumption as part of a weight-reducing diet on blood cholesterol and related biomarkers of coronary heart disease risk

ISRCTN	ISRCTN31221145
DOI	https://doi.org/10.1186/ISRCTN31221145
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Bruce Griffin
Scientific

School of Biomedical & Molecular Sciences
University of Surrey
Guildford
GU2 7XH
United Kingdom

Phone	+44 (0)1483879724
Email	b.griffin@surrey.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Ethics committee (ref: EC/2004/109/SBMS)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Eggs
Primary outcome measure	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 study start date	01/05/2005
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	01/04/2006

School of Biomedical & Molecular Sciences

Guildford
GU2 7XH
United Kingdom

British Egg Information Service (UK)
Other

126-128 Cromwell Road
London
SW7 4ET
United Kingdom

Other

British Egg Information Service (UK)

No information available

University of Surrey (UK) - Finance Office, RC4022

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008		Yes	No