The Effect of Alginate Supplementation on Weight Management - A Randomised Double Blind Placebo Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in amount of body fat
研究概览
简要总结
This project will assess the effect of the alginate (in a capsules) on the weight of generally healthy volunteers over a 12 week period.
To achieve this, will recruit 150 (non-smoking) generally healthy volunteers to attend the study centre on four separate occasions. Volunteers will be randomly allocated into active or placebo arm of the trial, both will receive capsules with the same appearance.
The volunteers will have their height, weight, waist circumference, body composition, and fasting levels of circulating glucose, triacylglycerol and cholesterol measured at each for the four visits.
详细描述
The study will last approximately 12 weeks depending on your availability.
Volunteers will be asked to come to the research facility in Newcastle University, before they have had any breakfast, on four separate occasions. The volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. This includes not drinking any alcohol, tea or coffee.
Each time the volunteers come in, their height (first assessment only), weight, waist circumference and body composition will be measured. Body composition is measured using scales which can determine the percentage of their body is fat or bone or muscle. This is done using a small harmless electrical current passing through their body, they will not detect or feel this at all. Their height will also be measured at the first visit. Cholesterol, triglyceride and glucose levels in the blood will also be measured at each visit. This will be done through a single finger prick blood sample.
Enough capsules will be given to the volunteers to last you four weeks at the first three visits. The capsules will be filled with either alginate or another dietary fibre believed to have no effect on weight management.
Volunteers will be asked to take four of these capsules with their three main meals per day over the 12 week study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither the researcher or the participant will know which arm of the trial they are part of.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •BMI over 20
排除标准
- •Pregnant, lactating,
- •BMI under 20
结局指标
主要结局
Change in amount of body fat
时间窗: 12 weeks
A change in body fat (as a percentage) as measured by impedance
Change in Weight
时间窗: 12 weeks
A change in weight measured in kg
次要结局
- Change in fasting Glucose(12 weeks)
- Change in waist circumference(12 weeks)
- Change in fasting Cholesterol(12 weeks)
- Change in fasting triacylglycerol(12 weeks)