A Randomised, Double-blind, Controlled, Crossover Study to Evaluate the Acute Effect on Glycemic Response and Related Biomarkers When Replacing Rapidly Digested Carbohydrates by β-glucan-rich Oat Bran Processed in Different Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax)
研究概览
简要总结
Whilst a cause-and-effect relationship between consumption of oat ß-glucans and reduction in PPGR has been demonstrated, little is understood about its:
- Application to liquid matrices: There are few studies which looked into the effect of a dose of ß-glucan applicable to beverages. Previous studies have explored oat ß-glucan doses between 2g to 13g per serving of test product (Note: the oat ß-glucan dose for the proposed trial is <2g).
- Impact following processing: Collectively, oat processing, ß-glucan structure and its physiological impact on PPGR are closely linked. Some studies have investigated the effect of oat processing or dosage on PPGR, but to our knowledge, no study has systematically characterised the effect of processing on oat structure, and clinically measured its subsequent impact on PPGR.
详细描述
The proposed study is a randomised, double blind, controlled, crossover trial to investigate the postprandial effects on glycemic response and related biomarkers/biological surrogates in five test product beverages:
This study will investigate the post-prandial effects of five test products, including two controls:
- Beverage powder with 12% oat bran processed with method A (Test Product: TP-1)
- Beverage powder with 12% oat bran processed with method B (Test Product: TP-2)
- Beverage powder with 12% oat bran processed with method C (Test Product: TP-3)
- Beverage powder with 12% minimally-processed oat bran (Positive Control) (Test Product: TP-PC)
- Beverage powder without oat bran (Negative Control) (Test Product: TP-NC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The test products are coded by group coding (A - E).
入排标准
- 年龄范围
- 24 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants, age between 24 and 39 years
- •Healthy individuals with no comorbidities or on regular medication
- •BMI between 18.5-25 kg/m2
- •Able to understand and willing to sign an informed consent form in English
- •Regularly consume breakfast
- •Able and willing to consume 330ml of liquid in 10 minutes
- •For female participants, have a regular menstrual cycle
排除标准
- •Known food allergies or intolerances specifically to gluten, milk, lactose or any grains
- •Known drug allergies specifically paracetamol
- •Known sensitivity or has had an adverse reaction to paracetamol and non-steroidal anti-inflammatory drugs (NSAID) in the past
- •Individuals with regular prescriptions or regularly consume medication (at least once a month), including alternative medicine (e.g. traditional Chinese medicine)
- •Had been diagnosed or with a history of any metabolic disease or disorders, including diabetes, gestational diabetes and hypertension
- •Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
- •Had been hospitalised in the 3 months prior to the study.
- •Pregnant or lactating women, or planning to conceive in the next 3 months
- •Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.
- •Poor peripheral venous access based on past experiences with blood draw
- •Significant change in weight (≥ 3 kg body weight) in the past 3 months
- •Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
- •Currently on a specialised diet e.g. vegetarian, vegan, weight loss plan, high protein diet
- •Unwilling to refrain from consuming fibre or prebiotic supplements, high fibre ingredients and more than 5 servings of fruits and vegetables per day over the length of the study.
- •Has donated blood in the past one month
- •Hierarchical link with the research team members
- •Participating in another clinical study
结局指标
主要结局
Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax)
时间窗: through study completion, an average of 7 months
Postprandial glycemic response reflected by time to achieve the peak plasma concentration (Tmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC)
时间窗: through study completion, an average of 7 months
Postprandial glycemic response reflected by 3-hour area under the plasma concentration versus time curve (AUC) assessed over all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Postprandial glycemic response - Peak Plasma Concentration (Cmax)
时间窗: through study completion, an average of 7 months
Postprandial glycemic response by the peak plasma concentration (Cmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
次要结局
- Gastric emptying rate(through study completion, an average of 7 months)
- Gastrointestinal comfort(through study completion, an average of 7 months)
- Postprandial insulin response (PPIR)(through study completion, an average of 7 months)
- Postprandial blood gastric inhibitory polypeptide (GIP)(through study completion, an average of 7 months)
- Ingredient fermentability by colonic bacteria(through study completion, an average of 7 months)
- Postprandial blood glucagon-like peptide 1 (GLP-1)(through study completion, an average of 7 months)
- Satiety(through study completion, an average of 7 months)