Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
01/10/2014
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 Rasha Mukhtar

ORCID ID

Contact details

Wolfson Centre
Royal United Hospital
Bath
BA1 3NG
United Kingdom
+44 (0)1225 428331
mpxrm@bath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0212177254

Study information

Scientific title

Acronym

Study hypothesis

To compare the effectiveness of three dietary regimes in improving cardiovascular risk in subjects with the metabolic syndrome.

Ethics approval

Not provided at time of registration

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

Nutritional, Metabolic, Endocrine: Metabolic syndrome

Intervention

Comparison of three dietary approaches

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improving the cardiovascular risks associated with the metabolic syndrome has long-term beneficial effects on health and quality of life. Management through dietary lifestyle changes is possibly the healthier option with less chances of side effects or interactions as would be expected through drugs.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2004

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Males or non-pregnant females fulfilling the criteria for the metabolic syndrome - these include the presence of three or more of the following:
1. Abdominal obesity (waist circumference >102 cm in men and >88 cm in women)
2. Triglyceride level >150 mg/dl
3. HDL cholesterol <40 mg/dl for men, <50 mg/dL for women
4. Blood pressure >130 mm systolic or 85 mm diastolic
5. Fasting plasma glucose >6.1 mmol/dl

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 - recruitment is completed as of July 2008

Participant exclusion criteria

1. Recent cardiovascular event, i.e. stroke, myocardial infarction or pulmonary embolism, within past 4 months
2. Ongoing chronic inflammatory condition: vasculitis, ulcers, inflammatory bowel disease, malignant disorder
3. Renal impairment (creatinine >135)
4. Hepatic impairment (ALT or AST> 4x upper limit of normal)
5. On statin therapy for dyslipaemia
6. Poorly controlled diabetes. Type 2 diabetes on insulin therapy. Type 2 diabetes on thiazolidinione
7. Untreated thyroid disorders - should be stable on thyroid medication for at least 3 months
8. Known Cushing's syndrome
9. On an anorectic agent, i.e., Orlistat, sibutramine - can be given a 4-week washout period
10. Food allergies/intolerance
11. Vegetarian

Recruitment start date

01/03/2004

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Centre
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Sponsor details

The Department of Health
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

Royal United Hospital Bath NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diabetes Research Fund

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

Publication citations

Additional files

Editorial Notes