A pilot comprehensive lifestyle intervention program (CLIP) - Comparison with qualitative lifestyle advice and simvastatin on cardiovascular risk factors in overweight hypercholesterolaemic individuals

Background and Aims: Escalating costs of pharmaceuticals for cardiovascular management highlight the need to develop effective lifestyle intervention programs to reduce reliance on these agents. The aim of this pilot study was to evaluate the efficacy of a Comprehensive Lifestyle Intervention Program (CLIP) compared with qualitative lifestyle advice (L) and Simvastatin plus qualitative lifestyle (S. +. L) on cardiovascular risk factors. Methods and Results: Sixty-five overweight adults with hypercholesterolemia were randomised to either L (qualitative advice on diet, exercise), S. +. L (20. mg/day Simvastatin plus L) or CLIP (6500. kJ structured menu plan: conventional and functional foods contributing <10% energy from saturated fat, ≥3. g soluble fibre, 2.4. g plant sterols, oily fish ≥2 times/week at lunch and dinner, plus exercise advice and self monitoring) for 6 weeks. LDL-cholesterol was lowered in CLIP (-0.57 ± 0.67. mmol/L, 15%) and S. +. L (-1.43 ± 0.59. mmol/L, 37%), but did not change significantly in L (-0.17 ± 0.59, 4%) (P< 0.001 time-by-treatment interaction). Weight and waist circumference were significantly lowered by CLIP (-4.2 ± 2.2 kg; -5.1 ± 2.3 cm) compared to L (-1.0 ± 1.6 kg; -2.7 ± 3.3 cm) and L. +. S (-0.7 ± 1.4 kg; -2.4 ± 2.3 cm), (P≤ 0.003 time-by-treatment interactions). B-carotene levels within treatment groups did not change over time and were not lowered by the CLIP diet compared to L (P> 0.05, all). Blood pressure changes were not different between groups. Conclusions: The structured CLIP program was more effective than qualitative lifestyle advice in improving weight, waist circumference and LDL-cholesterol without adverse effects on plasma carotenoids over a 6 week period. This program may therefore assist in comprehensive risk factor management, although the sustainability of these benefits needs confirmation.