Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/04/2012
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

Dr Gary Frost

ORCID ID

Contact details

Nutrition & Dietetics Department
2nd Floor
C Block
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3048(bleep 9027)
g.frost@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016141081

Study information

Scientific title

Acronym

Study hypothesis

To determine if body weight is maintained more effectively for six months when overweight or obese patients with a BMI of 27-50kg/m2 who have already lost 5% of initial body weight or more follow a low glycaemic index diet.

Ethics approval

Not provided at time of registration

Study design

Unpaired, parallel designed randomised controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Obesity

Intervention

Low glycaemic index diet vs no diet.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To look into the effect of a low GI diet on weight maintenance following weight loss.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/01/2004

Overall trial end date

15/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ages 18-65
2. Overweight and obese patients
3. With or without type 2 diabetes
4. With a BMI between 27-50 kg/m2
5. Who have lost 5% or more of their body weight after a weight reduction program

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/01/2004

Recruitment end date

15/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nutrition & Dietetics Department
London
W12 0HS
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

Hammersmith Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own Account NHS R&D Support Funding 2004/05

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. 2009 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/19057524

Publication citations

  1. Pilot study

    Philippou E, Neary NM, Chaudhri O, Brynes AE, Dornhorst A, Leeds AR, Hickson M, Frost GS, The effect of dietary glycemic index on weight maintenance in overweight subjects: a pilot study., Obesity (Silver Spring), 2009, 17, 2, 396-401, doi: 10.1038/oby.2008.533.

Additional files

Editorial Notes