健康人体中低 FODMAP 口服营养补充剂的胃肠道耐受性：一项随机对照试验。
Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial.
机构信息
Department of Food Science and Nutrition, University of Minnesota, 1334 Eckles Ave, St Paul, MN, 55108, USA.
Clinical and Translational Science Institute, University of Minnesota, 717 Delaware St SE, Minneapolis, MN, 55414, USA.
出版信息
Nutr J. 2017 May 25;16(1):35. doi: 10.1186/s12937-017-0256-3.
BACKGROUND
There has been increasing interest in utilizing a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) for the treatment of irritable bowel syndrome (IBS), a functional gastrointestinal disease. While studies have indicated that this diet can be effective at symptom reduction, it is a restrictive diet and patients may find it challenging to find low FODMAP products to meet their nutrient needs. The primary objective of this study was to assess the gastrointestinal (GI) tolerance of three low FODMAP oral nutrition supplements (ONS) in healthy adults.
METHODS
A double-blind randomized controlled crossover study was conducted in 21 healthy adults (19-32 years). Fasted subjects consumed one of four treatments at each visit, with a one week wash out period between visits. Each participant received all treatments. Treatments included three low FODMAP ONS formulas (A, B, and C) as well as a positive control consisting of 5 g fructooligosaccharides (FOS) mixed in lactose-free milk. Breath hydrogen was measured at baseline, 1, 2, 3, and 4 h post treatment consumption. Subjective GI symptom questionnaires were completed at baseline, 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 h following treatment consumption. Mean breath hydrogen concentrations and baseline corrected area under the curve for both breath hydrogen and GI symptoms were analyzed and compared between treatments. Significance was determined at P < 0.05.
RESULTS
The positive control resulted in higher breath hydrogen response compared to all three of the low FODMAP ONS beverages at 3 and 4 h after consumption. There were no differences in GI symptom response between treatments.
CONCLUSIONS
All treatments were well tolerated in healthy participants. The low FODMAP formulas resulted in a lower breath hydrogen response compared to the positive control, and may be better tolerated in individuals with IBS. More research should be conducted to better understand the GI tolerance of low FODMAP ONS in individuals with IBS.
TRIAL REGISTRATION
The protocol for this study was registered on ClinicalTrials.gov in January 2016 (Clinical Trials ID: NCT02667184 ).
背景
对于肠易激综合征（IBS）这一功能性胃肠道疾病，越来越多的人对采用低可发酵寡糖、双糖、单糖和多元醇（FODMAPs）饮食治疗感兴趣。虽然研究表明这种饮食可以有效减轻症状，但它是一种限制饮食，患者可能会发现很难找到低 FODMAP 产品来满足其营养需求。本研究的主要目的是评估三种低 FODMAP 口服营养补充剂（ONS）在健康成年人中的胃肠道（GI）耐受性。
方法
在 21 名健康成年人（19-32 岁）中进行了一项双盲随机对照交叉研究。空腹受试者在每次就诊时服用四种治疗方法中的一种，每次就诊之间有一周的洗脱期。每位参与者接受所有治疗。治疗方法包括三种低 FODMAP ONS 配方（A、B 和 C）以及 5g 果寡糖（FOS）混合在无乳糖牛奶中的阳性对照。在治疗后 1、2、3 和 4 小时测量呼吸氢。在基线、0.5、1、1.5、2、3、4、12、24 和 48 小时后，使用基线校正的呼吸氢和 GI 症状的曲线下面积来分析和比较治疗之间的主观 GI 症状问卷。在 P < 0.05 时确定显著性。
结果
阳性对照在摄入后 3 和 4 小时的呼吸氢反应高于所有三种低 FODMAP ONS 饮料。在治疗之间没有 GI 症状反应的差异。
结论
所有治疗在健康参与者中均耐受良好。低 FODMAP 配方与阳性对照相比，呼吸氢反应较低，在 IBS 患者中可能更耐受。应进行更多研究，以更好地了解 IBS 患者低 FODMAP ONS 的 GI 耐受性。
试验注册
本研究的方案于 2016 年 1 月在 ClinicalTrials.gov 上注册（临床试验 ID：NCT02667184）。
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