Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control.
研究概览
简要总结
The study is designed to determine whether seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin. It is designed as an acute, randomised, cross-over, controlled, three-arm dietary intervention trial in healthy subjects. Participants will be asked to consume either white bread, white bread with lower dose of seaweed extract or white bread with higher dose of seaweed extract.The effects on plasma glucose levels and levels of insulin will be determined over 3 hours after the consumption.
详细描述
It has been shown in a large number of in vitro studies that seaweed extracts act as potent inhibitors of enzymes of carbohydrate digestion suggesting their potential to modulate postprandial glycaemic response and prevent the damaging effects of hyperglycaemic state. However, the results from human trials are limited and inconsistent.
The investigators confirmed that the in vitro inhibitory effects of seaweed extracts depend on the type, level and ratio of bioactive compounds, and optimised the composition of the extract to obtain the most potent one, to be tested in the proposed study.
The present study will determine whether the seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin or determined by the individual levels of digestive enzymes.
Healthy volunteers will be asked to consume three different meals: (1) white bread; (2) white bread with the lower dose (LD) of the extract; (3) white bread with the higher dose (HD) of the extract
The levels of glucose and insulin will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
physically incorporated in the intervention
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years old
排除标准
- •Diagnosis of any chronic illness (including diabetes, hypertension, gastrointestinal diseases etc.)
- •On long term prescribed medication (except contraceptives)
- •Pregnant or lactating
- •On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements)
- •Allergy to fruits vegetables or pollen
- •Unwillingness to follow dietary recommendations or record the diet during recommended period
- •Donated blood 4 weeks before or intend to donate blood during the study or 4 weeks after the last study samples
- •Participation in another research project in parallel which also involves dietary intervention (e.g. taking vitamin supplements) or requires sampling of blood
结局指标
主要结局
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control.
时间窗: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of both levels of seaweed extracts concomitantly with white bread, or white bread only, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).
次要结局
- Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control(Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min)
- Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control(Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min)
研究者
Akristic
Assistant Professor
University College Dublin