NCT05100901终止不适用
Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents and Adults
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年9月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation
研究概览
简要总结
This is an open label, non-randomized, interventional, single arm study.
详细描述
Primary objective is to assess whether the MAG oil (monoacylglycerol oil) containing study formula is well tolerated and safe when used as an ONS in healthy adults and adolescents.
Secondary objectives:
- Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms
- Describe changes in stool characteristics, specifically stool frequency and consistency
- Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
- Describe changes in blood parameters of lipid metabolism
- Describe changes in hematological and serum biochemistry parameters
- Describe daily ONS intake and assess dietary adherence to the study protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •BMI range from >18 to <28 kg/m2 for adults with a minimum body weight of 45 kg
- •BMI range between the 25th and 90th percentile according to the Swiss growth charts for adolescents with a minimum body weight of 40 kg
- •Cohort 1: Adults aged 18+ years (6 males, 6 females)
- •Cohort 2: Adolescents aged 12-17 years (6 males, 6 females)
- •Deemed able to comply with study protocol for 2 weeks
- •Able to obtain written informed consent from participants and /or legal guardians
排除标准
- •Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician
- •Subjects taking dietary supplements (energy supplements, protein supplements) will be excluded. Subjects can continue taking vitamin or herbal supplements during the study period.
- •Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease (IBD), diverticular disease, colon cancer, irritable bowel syndrome (IBS), history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average, or chronic or recurrent diarrhea with loose or watery bowel movements more than 3 times daily.
- •Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
- •Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
- •Prior use of prescription medication(s), in particular antibiotics, antacids, laxatives or other medications impacting gastrointestinal transit time, within 8 weeks prior to enrolment.
- •Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
- •Known food allergy in particular cow's milk protein allergy (CMPA) or known hypersensitivity/intolerance to any other ingredients in the study product.
- •Known alcohol or substance abuse; specifically, alcohol intake > 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- •Pregnant or lactating women or having given birth in the past 6 months prior to enrolment.
- •Family or hierarchical relationships with Clinical Innovation Lab staff.
研究组 & 干预措施
Oral nutritional supplement
Experimental
Oral nutritional supplement that contains MAG oil
干预措施: MAG oil oral nutritional supplement (ONS) (Dietary Supplement)
结局指标
主要结局
Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation
时间窗: [ Time Frame: Day 2 to Day 15 ]
Number of subjects who develop gastrointestinal intolerance reported as adverse events related to the investigational product and leading to premature discontinuation of the study product, assessed by a daily questionnaire
次要结局
- Severity of gastrointestinal intolerance symptoms([ Time Frame: Day 1 and Day 15 ])
- Change in stool frequency([ Time Frame: Day 1 to Day 15 ])
- Change in weight([ Time Frame: Day 1 and Day 15 ])
- Change in triglycerides([ Time Frame: Day 1 and Day 15 ])
- Change in cholesterol([ Time Frame: Day 1 and Day 15 ])
- Change in fatty acids profile([ Time Frame: Day 1 and Day 15 ])
- Changes full blood count([ Time Frame: Day 1 and Day 15 ])
- Changes liver function([ Time Frame: Day 1 and Day 15 ])
- Changes in renal function([ Time Frame: Day 1 and Day 15 ])
- Changes in blood glucose([ Time Frame: Day 1 and Day 15 ])
- Daily intake of study product([ Time Frame: Day 1 to Day 15 ])
- Change in stool consistency([ Time Frame: Day 1 to Day 15 ])
- Change in BMI([ Time Frame: Day 1 and Day 15 ])
- Change in Fat soluble-vitamins profile([ Time Frame: Day 1 and Day 15 ])
- Change in serum biochemistry parameters([ Time Frame: Day 1 and Day 15 ])
- Severity of gastrointestinal intolerance symptoms([ Time Frame: Day 2 to Day 14 ])
研究者
研究点 (1)
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