The Texture, Eating Rate and Glycaemic Index (TERAGI) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reported satiety in response to test meal
研究概览
简要总结
Rationale: It is now recognized that diet plays a critical role in the etiology and management of chronic diseases such as type-2 diabetes, obesity and cardiovascular diseases. Evidence shows an increasing prevalence of type-2 diabetes as well as obesity, whereby large consumptions of carbohydrate foods is one of the leading contribution to these diseases. Food structure and texture can be modified to control oral processing behaviour, which would have subsequent impact on total energy intake and glycaemic response through altering the food breakdown path. Whilst it has been demonstrated that foods which are eaten at a faster rate leads to more food consumed ad-libitum and therefore higher energy intake, they are also eaten at fewer chews per bite, resulting in larger food particle sizes and hence slower digestion. Therefore it is important to understand the overall net effect of the opposing outcomes of food texture and oral processing behavior, bolus properties and glycaemic response, and identify the key factors which has the biggest influence on glycaemic response. The findings from this study can be used as guidelines on meal planning and making better informed choices between foods which are of the same composition/nutrition but with different health outcomes.
Study Aims: The aim of this study is to understand how food texture and saliva characteristics influences oral processing behavior, bolus characteristics and postprandial glycaemic response.
Study Design: Randomised crossover design where participants receive 2 treatments (i.e. 2 test meals) over 2 test sessions. Test sessions will include bolus characterisation of foods where participants chew and expectorate test foods (5g each) based on a fixed chew protocol.
Study Population: Up to 40 healthy males aged 21-50 years with BMI between 18-25 kg/m2
Intervention: For test session 1 and 2, participants will receive 2 treatments (i.e. 2 test meals) in randomised order over 2 sessions. The test meals contain 50g carbohydrate load of different textures. Participants will be video recorded while consuming the test meals to derive oral processing behaviour (bites, chews, time food spent in mouth). Blood samples will be collected at baseline and post consumption (5, 10, 15, 30, 45, 60, 90, 120 minutes) to measure glycaemic responses to the test meals. For test session 3, participants will be asked to follow a fixed chew protocol to chew and expectorate 3 test foods while being video recorded. Similarly, oral processing behaviours will be analysed from the recorded videos. The spat out food samples (i.e. bolus samples) will be analysed for saliva uptake and bolus particle size indicating extent of food breakdown.
详细描述
Study Aims:
The aim of this study is to understand how food texture and saliva characteristics influences oral processing behavior, bolus characteristics and postprandial glycaemic response.
The study hypothesizes that foods with a more elastic texture are eaten slower and requires more chewing, resulting in smaller bolus particle sizes and therefore higher postprandial glycaemic response due to an increased surface area for enzymatic digestion. Participants with higher saliva flowrate and/or alpha-amylase activity would also have shorter eating times and higher postprandial glycaemic responses.
Study Design:
Oral processing behaviours have high individual variances (Bolhuis et al 2013; Ketel et al 2019) and a large sample size is required in order to get significant differences between treatments. Based on previous papers on food texture and oral processing, a minimum of 20 healthy young male Chinese participants will be recruited in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Chinese ethnicity
- •Age between 21-40 years
- •Weigh at least 45 kg
- •Body mass index between 18to 25 kg/m²
- •Normal blood pressure (</=140/90 mmHg)
- •Fasting blood glucose <6.0 mmol/L
- •Healthy dentition and ability to bite, chew and swallow normally
- •No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding, no caries or periodontal disease and no impaired salivation functions
排除标准
- •Partake in sports at the competitive and/or endurance levels
- •Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Have known history of anaemia or thalassemia minor
- •Have major chronic disease such as heart disease, cancer or diabetes mellitus
- •Take insulin or drugs known to affect glucose metabolism
- •Intentionally restrict food intake
- •Have major medical or surgical event requiring hospitalization within the preceding 3 months
- •Have taken antibiotics for 3 months before the study period
- •Overnight shift worker
- •Have any known food allergy (eg. anaphylaxis to peanuts)
- •Have an active Tuberculosis (TB) condition or currently receiving treatment for TB
- •Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus(HCV), Human Immunodeficiency Virus (HIV)
- •Member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- •Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
- •Have poor veins impeding venous access
- •Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
结局指标
主要结局
Reported satiety in response to test meal
时间窗: During test session 2 (up to 3 hours)
Meal satiety responses using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during pre- and post- consumption of test meal (white rice or rice cake). VAS is anchored at 'Not at all full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Bolus characterisation of test meal
时间窗: During test session 2 (up to 3 hours)
Bolus characterisation of the test meal will be assessed by having participants chew a fixed mouthful of the test meal (white rice or rice cake, 5g) until ready to swallow, then expectorating it in a cup. Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
Oral processing behaviour of test meal
时间窗: During test session 2 (up to 3 hours)
Participants will be video-recorded to measure oral processing behaviour of the test meals (white rice or rice cake)
Blood glucose response to test meal
时间窗: During test session 2 (up to 3 hours)
Blood glucose response will be measured through blood samples collected via finger prick at baseline (i.e. 0 minute) and post consumption of test meal (white rice or rice cake). (i.e. 0 min, 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (0.5ml blood each)).
Reported sensory and textural rating of test meal
时间窗: During test session 2 (up to 3 hours)
Meal satiety responses after test meal (white rice or rice cake) is consumed will be assessed using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during test session 1. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.
Bolus characterisation of 3 test foods
时间窗: During test session 3 (up to 1 hour)
Bolus characterisation of the test meals will be assessed by having participants chew a fixed mouthful of the test foods (5g) based on a fixed chew protocol, then expectorating it in a cup. Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
次要结局
未报告次要终点