Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/09/2005
Date assigned
05/10/2005
Last edited
13/10/2009
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

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

http://www.britegg.co.uk

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

  1. 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.

Additional files

Editorial Notes