Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies.

IF 2.9 Q3 NUTRITION & DIETETICS Clinical nutrition ESPEN Pub Date : 2024-12-15 DOI:10.1016/j.clnesp.2024.12.014
Boutaina Zemrani, Laura-Florina Krattinger, Francesca Giuffrida, John Corthésy, Rinat Rivka Ran-Ressler, Jalil Benyacoub
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Abstract

Background & aims: Enteral formulas containing predigested lipids to support the needs of patients with fat maldigestion are currently unavailable. Monoacylglycerol (MAG)-rich oils offer potential benefits for fat absorption without prior digestion, but their safety and tolerability in enteral formulas need evaluation. We assessed the safety and tolerability of a new formula containing predigested lipids in the form of MAG-rich oil.

Methods: Two cohorts of healthy volunteers, consisting of 12 adults (aged ≥18 years) followed by 12 adolescents (aged 12-17 years) were recruited. Participants consumed an oral nutritional supplement containing MAG-rich oil as the main lipid source (up to 37 g/day) three times daily for 13 days. Safety, tolerability, gastrointestinal (GI) symptoms, anthropometric, and blood parameters were assessed.

Results: All 24 participants completed the study without discontinuing the formula with good compliance. Median Visual Analog Scale scores for GI symptoms were low (on average 0.2 out of 10) in both groups, and the Gastrointestinal Symptom Rating Scale scores remained mostly unchanged (1-2 out of 7), indicating no or minimal discomfort. Stool frequency and consistency remained within normal limits throughout the study. Serum triglyceride and cholesterol levels showed no clinically significant changes, and the fatty acid profile and fat-soluble vitamins showed a favorable trend at the end of the study. Adverse events (AEs) were minor, and none were serious.

Conclusions: The new formula containing MAG-rich oil was safe and well tolerated in healthy adults and adolescents. This formula could potentially address a gap in the nutritional management of patients with EPI and fat maldigestion. Further studies are required to assess the efficacy of this new formula in the target population.

Trial registration: https://clinicaltrials.gov/: NCT05100901 and NCT05923593.

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富含单酰基甘油的油脂作为一种新型预消化膳食脂肪来源用于健康成人和青少年的肠道配方食品的安全性和耐受性:两项单臂、开放标签研究。
背景与目的:目前还没有含有预消化脂质的肠内配方来满足脂肪消化不良患者的需求。富含单酰基甘油 (MAG) 的油类具有无需预先消化即可吸收脂肪的潜在益处,但其在肠内配方中的安全性和耐受性需要评估。我们评估了一种新配方的安全性和耐受性,该配方含有以富含 MAG 的油脂形式预先消化的脂质:招募了两组健康志愿者,包括 12 名成人(年龄≥18 岁)和 12 名青少年(年龄 12-17 岁)。参与者口服以富含 MAG 的油为主要脂质来源的营养补充剂(最多 37 克/天),每天三次,连续 13 天。对安全性、耐受性、胃肠道(GI)症状、人体测量和血液参数进行了评估:所有 24 名参与者都完成了研究,没有中断配方,依从性良好。两组胃肠道症状视觉模拟量表的中位数得分都很低(平均为 0.2 分(满分 10 分)),胃肠道症状评分量表的得分基本保持不变(1 至 2 分(满分 7 分)),表明没有或只有极少不适。在整个研究过程中,大便次数和稠度均保持在正常范围内。研究结束时,血清甘油三酯和胆固醇水平未出现临床显著变化,脂肪酸谱和脂溶性维生素呈良好趋势。不良反应(AEs)轻微,无严重不良反应:结论:富含 MAG 油的新配方对健康成人和青少年安全且耐受性良好。这种配方有可能填补 EPI 和脂肪消化不良患者营养管理方面的空白。要评估这种新配方在目标人群中的疗效,还需要进一步的研究。试验注册:https://clinicaltrials.gov/:NCT05100901和NCT05923593。
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来源期刊
Clinical nutrition ESPEN
Clinical nutrition ESPEN NUTRITION & DIETETICS-
CiteScore
4.90
自引率
3.30%
发文量
512
期刊介绍: Clinical Nutrition ESPEN is an electronic-only journal and is an official publication of the European Society for Clinical Nutrition and Metabolism (ESPEN). Nutrition and nutritional care have gained wide clinical and scientific interest during the past decades. The increasing knowledge of metabolic disturbances and nutritional assessment in chronic and acute diseases has stimulated rapid advances in design, development and clinical application of nutritional support. The aims of ESPEN are to encourage the rapid diffusion of knowledge and its application in the field of clinical nutrition and metabolism. Published bimonthly, Clinical Nutrition ESPEN focuses on publishing articles on the relationship between nutrition and disease in the setting of basic science and clinical practice. Clinical Nutrition ESPEN is available to all members of ESPEN and to all subscribers of Clinical Nutrition.
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