Battle of the Bulge - a randomised study comparing the effect of three dietary approaches on cardiovascular risk in subjects with the metabolic syndrome

ISRCTN	ISRCTN05118860
DOI	https://doi.org/10.1186/ISRCTN05118860
Secondary identifying numbers	N0212177254

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Rasha Mukhtar
Scientific

Wolfson Centre
Royal United Hospital
Bath
BA1 3NG
United Kingdom

Phone	+44 (0)1225 428331
Email	mpxrm@bath.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
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Battle of the Bulge - a randomised study comparing the effect of three dietary approaches on cardiovascular risk in subjects with the metabolic syndrome
Study objectives	To compare the effectiveness of three dietary regimes in improving cardiovascular risk in subjects with the metabolic syndrome.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Metabolic syndrome
Intervention	Comparison of three dietary approaches
Intervention type	Other
Primary outcome measure	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 study start date	01/03/2004
Completion date	01/05/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	120 - recruitment is completed as of July 2008
Key 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
Key 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
Date of first enrolment	01/03/2004
Date of final enrolment	01/05/2007

Royal United Hospital

Bath
BA1 3NG
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal United Hospital Bath NHS Trust (UK)

No information available

Diabetes Research Fund

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

17/05/2017: No publications found, verifying study status with principal investigator.