NCT05923593已完成不适用
Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents
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: 2023年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of subjects who develop significant gastrointestinal adverse events (deemed probably related or related to study product as per investigator's opinion) leading to discontinuation of the study product and withdrawal from the study
研究概览
简要总结
This is an open label, non-randomized, interventional, single arm study.
详细描述
The primary objective is to assess whether the MAG oil-containing study formula is well tolerated and safe when used as an ONS in healthy adolescents.
Hypothesis
The study product will be safe and well tolerated in healthy adolescents (as previously observed in adults).
Secondary objectives:
- Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms
- Describe 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 overall compliance
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 12-17 years
- •BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg.
- •Deemed able to comply with study protocol for the study period
- •Able to obtain written informed consent from participants and legally authorized representative(s)
排除标准
- •Pre-existing chronic medical or psychiatric conditions.
- •History of a chronic gastrointestinal disorder (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.), or chronic or recurrent gastrointestinal symptoms, including self-reported symptoms such as abdominal pain.
- •Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
- •History of chronic constipation (with passage of fewer than 3 spontaneous bowel movements per week on average or history of painful or hard bowel movements), OR chronic or intermittent diarrhea with loose or watery bowel movements ≥ 3 times per day.
- •Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
- •Prior use of prescription medication(s), in particular antibiotics, antiacids, laxatives, antidiarrheal agents or other medications impacting gastrointestinal transit time, within 3 weeks prior to enrolment.
- •Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
- •Subjects following a weight loss program including a low-carbohydrate or low-fat diet, ketogenic diet, intermittent fasting, or any other special diet.
- •Known food allergy in particular cow's milk protein allergy or known/suspected hypersensitivity or intolerance to any other ingredients in the study product. Subjects experiencing gastrointestinal symptoms when consuming dairy products or avoiding dairy in their diet should not participate in the study.
- •Subjects taking energy or protein supplements.
- •Known alcohol or substance abuse.
- •Pregnant or lactating females or having given birth in the past 6 months prior to enrolment. Pregnancy will be ruled out by performing a standard urine dipstick test to female participants of childbearing potential prior to enrolment.
- •Family or hierarchical relationships with Clinical Innovation Lab staff
结局指标
主要结局
Number of subjects who develop significant gastrointestinal adverse events (deemed probably related or related to study product as per investigator's opinion) leading to discontinuation of the study product and withdrawal from the study
时间窗: Day 2 to Day 15
Number of subjects who develop significant gastrointestinal adverse events leading to discontinuation of the study product and withdrawal from the study
次要结局
- Change in weight(Day 1 and Day 15)
- Changes in lipid profile in the blood(Day 1 and Day 15)
- Changes in renal function tests in the blood(Day 1 and Day 15)
- Change in stool frequency(Day 1 to Day 15)
- Change in BMI(Day 1 and Day 15)
- Change in Vitamin A level(Day 1 and Day 15)
- Changes in in fat-soluble vitamins(Day 1 and Day 15)
- Change in 25-hydroxy vitamin D level(Day 1 and Day 15)
- Daily intake of study product(Day 1 to Day 15)
- Changes in fatty acids profile(Day 1 and Day 15)
- Change in vitamin E level(Day 1 and Day 15)
- Severity of gastrointestinal intolerance symptoms(Day 1 and Day 15)
- Change in stool consistency(Day 1 to Day 15)
- Changes in Vitamin K level(Day 1 and Day 15)
- Changes in liver function tests in the blood(Day 1 and Day 15)
- Changes in blood chemistry tests(Day 1 and Day 15)
- Changes in full blood count(Day 1 and Day 15)
研究者
研究点 (1)
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