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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05118860
Enrollment
120
Registered
2006-09-29
Start date
2004-03-01
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine: Metabolic syndrome Nutritional, Metabolic, Endocrine Metabolic syndrome

Interventions

Comparison of three dietary approaches

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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 130 mm systolic or 85 mm diastolic 5. Fasting plasma glucose >6.1 mmol/dl

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026