Elsevier

Nutrition

Volume 25, Issues 11–12, November–December 2009, Pages 1129-1136
Nutrition

Applied nutritional investigation
Efficacy and safety of very-low-calorie diet in Taiwanese: A multicenter randomized, controlled trial

https://doi.org/10.1016/j.nut.2009.02.008Get rights and content

Abstract

Objective

Very-low-calorie diets (VLCDs) are an effective method for weight reduction in Caucasians. This study investigated the efficacy and safety of two different VLCDs (450 or 800 kcal/d) in obese Taiwanese.

Methods

132 participants with BMI ≥30 kg/m2 were randomized to two VLCD groups for body weight reduction for 12 weeks. Each group had 66 participants. Anthropometric and metabolic parameters were measured.

Results

The intention-to-treat analysis revealed that the percentage change in body weight over the 12-week treatment period was –9.14% in the VLCD-450 group and –8.98% in the VLCD-800 group. A total of 27 (40.9%) participants in the VLCD-450 group and 29 (43.9%) participants in the VLCD-800 group achieved 10% or more weight loss at the end of treatment. The body weight, waist circumference, hip circumference, fat mass, blood pressure, triglycerides, and blood glucose were statistically improved from baseline but not between the two groups. The improvement rate of nonalcoholic fatty liver disease (NAFLD) was 41.5% in the VLCD-450 group and 50.0% in the VLCD-800 group. The incidence of adverse events did not differ significantly between the groups and no serious adverse events were reported in either group.

Conclusion

Both the VLCD-450 and 800 kcal/d can effectively and safely reduce body weight and improve NAFLD in 12 weeks in obese Taiwanese participants. However, there is no additional benefit in prescribing the more restrictive diet intervention in Taiwanese.

Introduction

Obesity is associated with a high comorbidity rate and all-cause mortality [1], [2]. Nonpharmacological intervention of obesity can never be overemphasized, but is often discouraged by the high attrition rate [3]. Because the effect of a conventional low-calorie diet (LCD) treatment in moderate to severely obese subjects is often minimal [4], very-low-calorie diets (VLCDs) were developed [5]. A VLCD was defined as a hypocaloric diet containing 800 kcal or fewer per day. VLCDs have been used successfully by obese Caucasian persons who failed to lose weight with a conventional LCD [5], [6], [7], [8]. The imbalance between food intake and energy expenditure is the major factor that can lead to obesity. In the weight reduction program, dietary intervention is always the first and major step in weight loss, not the physical activity [9]. It would be expected that lower energy intake contributes to greater weight reduction. Previous studies in Caucasians, however, have found that weight loss does not significantly differ between dietary interventions of 240 kcal/day and 800 kcal/day [10], [11]. In Taiwan, obesity has become a pervasive problem [12]. According to national surveys, the prevalence of obesity has increased steadily from 1980 to 2000, especially in children and in men [12], [13]. Many intervention programs have been tried but the results have been disappointing. There have been no well-designed studies of a VLCD in Taiwanese subjects. On the other hand, racial differences with obesity have been found previously. Obesity-related complications have been found to occur at a lower body mass index (BMI) in Asians than in Caucasians [14]. For a given BMI, Asians have greater body fat accumulation than do Caucasians [15]. Furthermore, racial differences may exist in the treatment of obesity. For example, Harvin et al. and Capella et al. reported that Caucasian women lost more weight than African-American or Hispanic females after obesity surgery [16], [17]. Therefore, in this study we investigated the efficacy and safety of two different VLCDs (450 or 800 kcal/day) in obese patients in Taiwan.

Section snippets

Subjects

Obese Taiwanese subjects (BMI ≥30 kg/m2) aged 18–65 y who visited the obesity special outpatient clinics of three tertiary hospitals located in northern, central, and southern Taiwan were recruited. Exclusion criteria included participants: with concomitant diseases including type 1 or 2 diabetes mellitus; severe infection; insufficient renal function (serum creatinine >133 μmol/L); insufficient liver function (transaminases: alanine transaminase [ALT] or aspartate transaminase [AST] >2 X upper

Subjects

There were 164 participants recruited in the screening, 132 of whom (BMI = 34.2 ± 3.7 kg/m2) were randomized to the two treatment groups (each group = 66; Table 1). The other 32 participants who failed to meet inclusion criteria were excluded. There were no significant differences in demographic characteristics and laboratory tests between the two VLCD treatment groups. Of the 132 participants, 95 (72%) completed the study (71.2% in VLCD-450 and 72.7% in VLCD-800).

Treatment efficacy

The percentage change from baseline

Discussion

In this study, we demonstrated that both VLCD-450 kcal/d and VLCD-800 kcal/d are efficacious and safe in obese Taiwanese participants. Consistent with a previous report in African-American and Caucasian obese women [19], our results showed that participants on both the VLCD-450 and the VLCD-800 treatment not only lost about 9% of BW on average after 12 weeks of treatment, but also had an average reduction of nearly 20% in fat mass percentage. Although the average weight loss was about 9% in our

Conclusion

Both the VLCD-450 and VLCD-800 kcal/d programs can effectively and safely reduce BW and improve NAFLD in 12 weeks in obese Taiwanese participants. However, there is no additional benefit in prescribing the more restrictive diet intervention in Taiwanese. Finally, considering that the weight reduction was not enhanced using the greater energy deficit, aberrant physiological compensatory responses must be considered.

Acknowledgments

We thank Professor Tsai-Chung Li and Miss Chia-Ing Li for their kindly help in the statistical analysis and thank Dr. F. Xavier Pi-Sunyer for his kindly revised the paper. We thank Nestle Taiwan Ltd. to provide the study materials. We also thank that National Science Council of Taiwan (NSC 93-2314-B-006-110, NSC 94-2314-B-006-119) and China Medical University Hospital (DMR-92-016, DMR-97-149) to provide the study grants.

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