Development of a Biomarker to Assess Adherence to Nutrients Supplements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- urinary concentration of saccharin (nmol/L)
研究概览
简要总结
The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements.
详细描述
The investigators will assess whether urinary concentrations of selected adherence markers can be used to distinguish between daily or intermittent consumption of lipid-based nutrient supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •non-pregnant, non-lactating women
排除标准
- •BMI <18.5kg/m2 or >25.0 kg/m2
- •Diagnosis of chronic disease
- •Use of medication that can affect gastrointestinal mobility
- •Consumption of more than 7 alcoholic drinks per week
- •Unwillingness to refrain from consuming dietary sources of the marker compound(s) 3 days prior to, and during the 12 day urine collection period
- •Unwillingness to adhere to the study protocol
- •Peanut allergy
- •Cow milk allergy
- •Soy allergy
- •Almond allergy
- •Allergy to adherence markers
- •Pregnancy
研究组 & 干预措施
Daily
Daily supplementation with product containing markers
干预措施: lipid-based nutrient supplement containing adherence markers (Dietary Supplement)
Control
Daily supplementation with product not containing markers
干预措施: lipid-based nutrient supplement not containing adherence markers (Dietary Supplement)
Intermittent
Daily supplementation with either the product containing markers or the product not containing markers
干预措施: lipid-based nutrient supplement containing or not containing adherence markers (Dietary Supplement)
结局指标
主要结局
urinary concentration of saccharin (nmol/L)
时间窗: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of saccharin (nmol/g creatinine)
时间窗: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of resveratrol metabolites (nmol/L)
时间窗: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates
urinary concentration of resveratrol metabolites (nmol/g creatnine)
时间窗: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates
次要结局
未报告次要终点