Investigating the Effects of Seaweed Extract on Postprandial Blood Glucose Response to Sucrose in Healthy Subjects
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control.
研究概览
简要总结
This study will examine the impact of the seaweed (Ascophyllum nodosum) extract on blood glucose levels after a sugary drink in healthy subjects.
The aim of this study is to investigate if the seaweed extract, when consumed with the sucrose, can lower blood glucose levels, compared to the raise after sucrose only, in healthy volunteers.
The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels will be determined over 2 hours after the consumption.
详细描述
Blood glucose levels after a meal rich in sugars depend, among other factors, on the activity of enzymes that digest sugar molecules to glucose. Epidemiological studies suggest that glucose levels after a meal higher than normal, present a great risk for the onset of cardiovascular diseases. Slowing the digestion of sugar through the inhibition of digestion enzymes have been demonstrated as a successful approach in preventing postprandial hyperglycaemia either with pharmacological agents (acarbose, miglitol) or natural dietary compounds.
We demonstrated, in preclinical in vitro experiments, the unique potential of tested seaweed extract to inhibit rat sucrase.
This study will examine the potential of the seaweed extract to modulate blood glucose levels after a sucrose drink in healthy subjects .
The aim of this study is to investigate if the seaweed extract, when consumed with sucrose, can lower blood glucose levels, compared to the raise after sucrose only.
The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels (in capillary blood) will be determined over 2 hours after the consumption. All participants will be characterized for the activity of salivary a-amylase
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years
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, pollen or seaweed.
- •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
研究组 & 干预措施
Control: Sucrose solution
Participants will consume 50g of sucrose dissolved in 500 ml of tap water
干预措施: Sucrose solution (Dietary Supplement)
Experimental: Seaweed extract in sucrose solution
Participants will consume 50g of sucrose and 1g of seaweed extract dissolved in 500 ml of tap water
干预措施: Seaweed extract in sucrose solution (Dietary Supplement)
结局指标
主要结局
Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control.
时间窗: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes
The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120 minutes) as the change in capillary blood glucose levels after the consumption of seaweed extract in sucrose solution or sucrose solution, compared to the glucose levels before the consumption of test drinks (baseline value, t=0 minutes)
次要结局
- Changes in area under the curve of incremental capillary blood glucose levels (iAUC) in the intervention group vs. control(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes)
研究者
Akristic
Assistant Professor
University College Dublin