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奥利司他的疗效:一项为期12周的随机对照试验及对早期研究的综述。

Efficacy of Olibra: a 12-week randomized controlled trial and a review of earlier studies.

作者信息

Rebello Candida J, Martin Corby K, Johnson William D, O'Neil Carol E, Greenway Frank L

机构信息

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, USA.

出版信息

J Diabetes Sci Technol. 2012 May 1;6(3):695-708. doi: 10.1177/193229681200600326.

DOI:10.1177/193229681200600326
PMID:22768902
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3440037/
Abstract

BACKGROUND

Intervention strategies that harness the body's appetite and satiety regulating signals provide a means of countering excessive energy intake.

METHODS

Eighty-two subjects were enrolled (18-60 years, body mass index: 25-40 kg/m(2)) in a randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, the effects of Olibra™ fat emulsion (2.1 g twice daily) on food intake, appetite, satiety, weight, and body composition were compared with those of a twice daily administered placebo (1.95 g milk fat). On days -7, 0, and 28, Olibra or the placebo added to 200 g of yogurt was served at breakfast and lunch. Food intake, appetite, and satiety were assessed after lunch and dinner. Body weight was measured on days -7, 0, 14, 28, 56, and 84. Body fat, waist circumference, and waist-hip ratio were determined on days 0 and 84. The Eating Inventory was administered at screening and on day 28. Data relating to 71 subjects were analyzed using analysis of covariance.

RESULTS

At 12 weeks, body weight was reduced in the test group (2.17 ± 0.46 kg standard error of the mean, p < .0001) and the control group (1.68 ± 0.42 kg, p < .0001). Waist circumference decreased by 2.93 ± 0.85 cm in the test group (p = .001) and by 1.78 ± 0.74 cm in the control group (p = .02). Differential weight and waist circumference reductions were not significant. Hunger scores (Eating Inventory) decreased more in the test group (p = .0082). Differential group effects were not significant for body fat, waist-hip ratio, food intake, appetite, and satiety.

CONCLUSIONS

At this dose, Olibra did not exert a consistent effect on food intake, appetite regulation, body weight, or body composition.

摘要

背景

利用人体食欲和饱腹感调节信号的干预策略为对抗能量摄入过多提供了一种方法。

方法

82名受试者(年龄18 - 60岁,体重指数:25 - 40kg/m²)参与了一项随机、安慰剂对照、双盲、平行试验。在12周期间,将奥利司他™脂肪乳剂(每日两次,每次2.1g)对食物摄入量、食欲、饱腹感、体重和身体成分的影响与每日两次服用的安慰剂(1.95g乳脂肪)进行比较。在第 -7、0和28天,将奥利司他或安慰剂添加到200g酸奶中,于早餐和午餐时提供。在午餐和晚餐后评估食物摄入量、食欲和饱腹感。在第 -7、0、14、28、56和84天测量体重。在第0和84天测定体脂、腰围和腰臀比。在筛查时和第28天进行饮食量表评估。使用协方差分析对71名受试者的数据进行分析。

结果

在12周时,试验组体重减轻(平均标准误为2.17 ± 0.46kg,p <.0001),对照组体重减轻(1.68 ± 0.42kg,p <.0001)。试验组腰围减少2.93 ± 0.85cm(p =.001),对照组腰围减少1.78 ± 0.74cm(p =.02)。体重和腰围的差异减少不显著。试验组饥饿评分(饮食量表)下降更多(p =.0082)。在体脂、腰臀比、食物摄入量、食欲和饱腹感方面,组间差异不显著。

结论

在此剂量下,奥利司他对食物摄入量、食欲调节、体重或身体成分未产生一致的影响。

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