Role of the Fruit Matrix on the Absorption of Glucose From Orange Juice in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes.
研究概览
简要总结
QUALIFICATION: Role of the fruit matrix in glucose absorption from orange juice in healthy human volunteers.
MAIN OBJECTIVE:
Added sugars may have different effects on glycemic response than natural sugars present in fruit juice. The juice matrix (fiber, polyphenols, citric acid, vitamins, minerals) may positively influence this glycemic response. The main objective of this project is to investigate how, for the same qualitative and quantitative sugar composition, the variation in the percentage of fruit matrix present in the juice may affect the glycemic response in healthy male participants.
CLINICAL STUDY:
This is a randomized, double-blind, dose-response, crossover study in healthy male adult participants (18-45 years, 18.5-29.9 kg/m2, N=30). The participants will repeat the entire study (duplicate results) to address interindividual variability and increase the reliability of the results. Participants who agree to take part in the study will complete a series of validated questionnaires about their lifestyle habits. The company AMC Natural Drinks (Murcia, Spain) will prepare the following juices: 100% orange juice versus 50% orange juice and 0% orange juice (same sugar composition as 100% juice but with reduced or absent matrix, respectively). The drinks will be fully characterized in their composition.
The day before each trial, participants will complete a food diary to verify compliance with a polyphenol-free diet and estimate the amount of nutrients consumed (carbohydrates, fiber, water). They will arrive at the UCAM laboratory on an empty stomach where they will drink each of the juices on separate dates. The researchers will measure glycemic response by vein cannulation at baseline (0 min, baseline) and after the consumption of the drinks (time points: 15, 30, 45, 60, 90 and 120 minutes). Results will be compared with the response to a single oral dose of glucose (glycemic index). The participants will repeat some of the test drinks (total: 6 interventions at least 2 or 3 days apart). The researchers will also measure insulin (at the same time points after drinking the test drinks) and analyze the differences in the effects on glycemic and insulin responses between the three types of juices using appropriate statistical analysis.
详细描述
Project proposal: Role of the fruit matrix on the absorption of glucose from orange juice in humans (ZULEMA)
Background assumptions: Excessive consumption of free sugars can have negative health effects and, poor post-prandial control of glucose could be a marker for longer term type 2 diabetes risk. Sugars drive the glycemic index (GI) of beverages but, contrary to expectations, fruit juices and sugar-sweetened beverages provide different GI results despite often having the same total sugar content. This implies that natural and added sugars may have different effects on glycemic control, or that the combination of sugars within the juice matrix is somehow ameliorating the effect of the sugars on glycemic control.
Research question: How does varying the matrix and source of sugars but not total sugars in fruit juices and drinks impact GI? The researchers assume that the free sugars will be the driver of GI but this may not be the case.
Hypothesis: For the same amount of free sugars (sucrose, glucose and fructose) in juices and beverages, the fruits juice matrix (i.e. fiber, complex carbohydrates, citric acid, polyphenols and other phytochemicals, minerals, vitamins), will have a modulatory effect on the absorption of glucose.
Objective: The primary objective of this study is to assess the effect of the presence of the juice matrix in 100% orange juice against manipulated juice drinks (to reduce the percentage of fruit matrix) on postprandial glycemia responses in healthy subjects. The secondary objective will be to characterize the effect on the insulin response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Test beverages will be served cold in plastic bottles with lids.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 and 29.9 kg/m2
- •To be habitual breakfast consumers
- •To be willing to consume the study beverages
排除标准
- •To be on a diet
- •To have food allergies
- •To have some kind of sensitiviness or aversion to beverages in this study
- •To have had significant weight fluctuations within the past 6 months
- •Previous diagnosis of diabetes or pre-diabetes
- •Previous diagnosis of other gastrointestinal disease
- •Previous diagnosis of liver disease
- •Previous diagnosis of kidney disease
- •Previous diagnosis of a metabolic disorder
结局指标
主要结局
Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes.
时间窗: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.
Blood glucose samples collected via vein cannulation. Glucose measured using a Glucose Oxidase (GOD) Activity Assay Kit (E-BC-K520-M) (Elabscience, Texas, USA).
次要结局
- Peak Blood Glucose Concentration(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
- Blood Glucose Concentration at 15 Minutes(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
- Time to peak concentration for glucose(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
- Incremental Area Under the Curve (iAUC) of blood insulin over 120 minutes.(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
- Peak Blood Insulin Concentration(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
- Blood Insulin Concentration at 15 Minutes(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
- Time to peak concentration for insulin(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.)
研究者
María-Teresa García-Conesa
Senior Researcher
Centro de Edafología y Biología Aplicada del Segura