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Double-blind, randomized feedback control fails to improve the hypocholesterolemic effect of a plant-based low-fat diet in patients with moderately elevated total cholesterol levels

Abstract

Objective: To determine whether the cholesterol-lowering effect of a plant-based low-fat diet can be improved by a flexible control design that controls the extent of fat reduction based on the individual response of blood cholesterol.

Design: Randomized, double-blind intervention study.

Setting: A hotel in Prerow, Germany.

Subjects: A total of 32 participants (21 female and 11 male participants) with total cholesterol level>5.7 mmol/l.

Intervention: The control group consumed a plant-based low-fat diet with constantly 20% of energy as fat; the intervention group received a diet with either 20 or 15% of energy as fat, depending on the serum cholesterol response of the preceding week. A flexible control design based on the individual cholesterol response during a run-in period of 1 week was used within a low-fat intervention.

Results: During the run-in period, the consumption of a plant-based low-fat diet led to a reduction in total cholesterol by 18±6 mmol/l (P<0.001), in LDL cholesterol by 19±9 mmol/l (P<0.001) and triglycerides by 13±3 mmol/l (P<0.001). During the feedback control period, an additional reduction in total cholesterol by 13±8 (P<0.001) and in LDL cholesterol by 17±11 (P<0.001) was observed compared to 15±15 and 7±18 in the control group. The effect of an additional feedback control was only marginal and not statistically significant compared to the effect of the low-fat diet alone.

Conclusions: On a level of fat intake already reduced to 20% of energy, the use of a feedback control to adapt the fat content of the diet depending on the individual serum cholesterol response was not more effective in reducing blood cholesterol levels than a plant-based low-fat diet alone.

Sponsorship: Institute of Micro-Ecology, Herborn; the Stoll VITA Foundation, Waldshut; ALBAT+WIRSAM Software, Linden; Reformhaus Technical College, Oberstedten; Kölln Flocken Werke, Elmshorn, all in Germany.

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Acknowledgements

This project was supported by the Institute of Micro-Ecology, Herborn; the Stoll VITA Foundation, Waldshut; ALBAT+WIRSAM Software, Linden; Reformhaus Technical College, Oberstedten; Kölln Flocken Werke, Elmshorn, all in Germany. We are grateful to the staff of the hotel ‘Haus Linden’ for all their efforts. We also thank the study participants for their excellent compliance.

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Guarantor: C Koebnick.

Contributors: SPH, BW, AH, CL, HJFZ and CK contributed to the design of the study. SPH, BW, CL and HJFZ were available for the participants during the study period in the study center. CK and SPH were responsible for the statistical analysis and interpretation of the data. CMK contributed to the laboratory analysis. All authors contributed to the conduct of the study, data collection and writing of the manuscript.

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Correspondence to C Koebnick.

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Koebnick, C., Plank-Habibi, S., Wirsam, B. et al. Double-blind, randomized feedback control fails to improve the hypocholesterolemic effect of a plant-based low-fat diet in patients with moderately elevated total cholesterol levels. Eur J Clin Nutr 58, 1402–1409 (2004). https://doi.org/10.1038/sj.ejcn.1601984

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