Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- GI function
研究概览
简要总结
Acceptability and tolerance of a new food product in adults and children.
详细描述
Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. The participants will record amount of daily intake, and will be given an entry and exit surveys. These surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. Acceptability will be measured as the number of servings and portion of serving completed each day over the trial period.
In adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, 40-60 years old
- •Male or Female 9-13 years old
- •Subject is willing and able to comply with the study protocols
- •Subject is willing to consume the test products
排除标准
- •Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- •Under current medical supervision
- •Non-English speaking
- •Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
- •Currently taking prescription drugs or supplements
- •Daily use of aspirin and or non-steroidal anti-inflammatory medicines.
- •Indications of substance or alcohol abuse within the last 3 years
- •Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
- •Self-reported malabsorption
- •Current enrollee in a clinical research study.
研究组 & 干预措施
Adult
Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks
干预措施: Food Product 1 (Other)
Children
Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks
干预措施: Food Product 1 (Other)
结局指标
主要结局
GI function
时间窗: at 2 weeks
GI function questionnaire with categorical numerical score
次要结局
未报告次要终点