Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in blood triglyceride concentration
研究概览
简要总结
The purpose of this study is to assess the glycaemic controlling effects of BSG and bio-transformed BSG-containing biscuits in Singapore adults with MetS. The investigators hypothesized that consumption of BSG and bio-transformed BSG containing biscuit will improve glycaemic control.
详细描述
This is a double-blind, randomised, crossover experiment. During the 3-week, 19 subjects will participate in a 3 meal tolerance test (MTT). During each MTT session, all subjects are required to consume 90 g biscuits (either control, autoclaved BSG or bio-transformed BSG biscuits) and monitored over a period of 240 minutes. All three types of biscuits will be consumed at a randomised sequence during this 3-week period. Post-prandial blood glucose, insulin, lipid and amino acid responses, breath analysis, body composition, blood pressure, appetite assessment, and any other glycaemic biomarkers will be assessed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants, aged 35-85 years old
- •English-literate and able to give informed consent in English
- •Willing to follow the study procedures
- •Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference > 102 cm (male), > 88 cm (female) (For Asian population: Waist circumference > 90 cm (male), > 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/85 mmHg or on medication);
排除标准
- •Significant change in weight (≥ 3 kg body weight) during the past 3 months
- •Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits.
- •Acute illness at the study baseline
- •Exercising vigorously* over the past 3 months. *Defined as having > 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day
- •Following any restricted diet (e.g. vegetarian)
- •Have a daily intake of more than 2 alcoholic drinks per day
- •Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.)
- •Consumption of antibiotics over past 3 months.
- •Pregnant, lactating, or planning pregnancy in the next 6 months
- •Insufficient venous access to allow the blood collection
- •Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation
- •High current intake of fibre* from brown rice or wholemeal products. *High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines
- •High current intake of fibre* from vegetables. * High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines
结局指标
主要结局
Change in blood triglyceride concentration
时间窗: Every week (week 1, week 2 and week 3)
Triglyceride concentration in the blood will be measured
Change in blood amino acid concentration
时间窗: Every week (week 1, week 2 and week 3)
Amino acid concentration in the blood will be measured
Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
时间窗: Every week (week 1, week 2 and week 3)
Low-density Lipoprotein-cholesterol concentration in the blood will be measured
Change in blood glucose concentration
时间窗: Every week (week 1, week 2 and week 3)
Glucose concentration in the blood will be measured
Change in blood insulin concentration
时间窗: Every week (week 1, week 2 and week 3)
Insulin concentration in the blood will be measured
Change in High-density Lipoprotein-cholesterol (HDL) concentration
时间窗: Every week (week 1, week 2 and week 3)
High-density Lipoprotein-cholesterol concentration in the blood will be measured
Change in blood cholesterol concentration
时间窗: Every week (week 1, week 2 and week 3)
Total cholesterol concentration in the blood will be measured
次要结局
- Change in appetite assessed by visual analogue scale(Every week (week 1, week 2 and week 3))
- Change in breath CH4 and H2 concentrations(Every week (week 1, week 2 and week 3))
- Change in waist circumference(Every week (week 1, week 2 and week 3))
- Change in blood pressure(Every week (week 1, week 2 and week 3))
- Change in weight and height(Every week (week 1, week 2 and week 3))
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore
