Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in fecal bile acids before and after a 3 week intervention.
研究概览
简要总结
This research project aims to provide the scientific findings about the beneficial effects of okara (soybean pulp) consumption on gut and glycaemic health in middle-aged and older individuals in Singapore. In addition, it aims to examine the health promoting impact of bio-transformed okara in this population. We hypothesise that consuming a habitual diet with an okara (untreated or bio-transformed) incorporated food product will improve the gut microbiome composition and will increase the production of short chain fatty acids when compared to a same diet with no okara. Okara-based food product can also improve the glycaemic response in individuals compared to a product without okara in meal tolerance test (acute).
详细描述
For this double-blind, randomized, crossover experiment, the participants will complete a 16-week study period. Following a 1-wk pre-intervention baseline period, each participant will be randomly assigned to consume their habitual diet that either contains or do not contain okara food product (untreated and bio-transformed okara) for 3 weeks. The food product will be equivalent to a consumption of 20 g of okara (dried) per day. Following a 3-week dietary 'washout' period, the participants will be assigned to consume the other diets for another 3 weeks. This process will be repeated until each participant have completed all three interventions. Fecal and fasting-state blood samples will be obtained at study weeks 1, 4, 7, 10, 13, and 16, which correspond to before and end of the three 3-week intervention periods.
Additionally, during Weeks 1, 7 and 13, fasted participants will also be required to undergo a meal tolerance test. A cannula will first be inserted into the participant's forearm for blood sampling by a trained phlebotomist. One of three meals prepared by designated study personnel will then be randomly assigned during each visit, namely, control biscuit, untreated okara biscuit and bio-transformed okara biscuit. During each test, the participants will eat the prepared meal within 10 minutes and have blood samples drawn by intravenous cannulation at time = 0, 15, 30, 45, 60, 90, 120, 180 and 240 min, with time 0 being the time the participants first start eating the biscuits. The blood samples will analyzed for the postprandial blood glucose, insulin responses and lipid levels.
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)
盲法说明
Primary investigator of the study will be blinded in this intervention trial through blinding of the intervention allocation to subjects.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give an informed consent
- •Age 50 to 75 years
- •Willing to follow the study procedures
排除标准
- •All subjects meeting any of the exclusion criteria at baseline will be excluded from participation
- •Significant change in weight (≥ 3 kg body weight) during the past 3 months
- •Allergy to soy-based products
- •Acute illness at the study baseline
- •Exercising vigorously over the past 3 months
- •Following any restricted diet (e.g. vegetarian)
- •Have a daily intake of more than 2 alcoholic drinks per day
- •Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation
- •Taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, probiotic supplement etc.)
- •Pregnant, lactating, or planning pregnancy in the next 6 months
- •Insufficient venous access to allow the blood collection
- •Very high intake of fibre/ vegetables on a daily basis
结局指标
主要结局
Change in fecal bile acids before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Bile acids will be determined via serum samples of subjects at baseline and after each intervention period.
Change in blood triglyceride levels before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Total triglyceride levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Change in gut microbiome composition before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Gut microbiome composition will be determined via fecal samples of subjects at baseline and after each intervention period.
Change in serum zonulin before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Serum zonulin will be determined via serum samples of subjects at baseline and after each intervention period.
Change in serum short chain fatty acids (SCFA) before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
SCFA will be determined via serum samples of subjects at baseline and after each intervention period.
Change in blood glucose levels before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Glucose levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Change in fecal short chain fatty acids (SCFA) before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
SCFA will be determined via fecal samples of subjects at baseline and after each intervention period.
Change in blood insulin levels before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Insulin levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Change in blood insulin levels over acute trial period
时间窗: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Insulin levels will be determined via fasted blood samples of subjects and after consumption of intervention
Change in blood short-chain fatty acids levels over acute trial period
时间窗: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Short-chain fatty acids levels will be determined via fasted blood samples of subjects and after consumption of intervention
Change in blood amino acid levels over acute trial period
时间窗: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention
Change in blood cholesterol levels before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Total cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Change in blood low-density lipoprotein-cholesterol levels before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
Low-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Change in blood glucose levels over acute trial period
时间窗: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Glucose levels will be determined via fasted blood samples of subjects and after consumption of intervention
Change in blood high-density lipoprotein-cholesterol levels before and after a 3 week intervention.
时间窗: Baseline and post-intervention (at 3 weeks)
High-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
次要结局
- Appetite assessment(Baseline and post-intervention (at 3 weeks))
- Change in blood pressure(Baseline and post-intervention (at 3 weeks))
- Change in anthropometric measurements(Baseline)
- Cognitive assessment(Baseline and post-intervention (at 3 weeks))
- Change in blood low-density lipoprotein-cholesterol levels over acute trial period(Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).)
- Change in blood amino acids levels over acute trial period(Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).)
- Dietary assessment(Baseline and post-intervention (at 3 weeks))
- Change in blood triglyceride levels over acute trial period(Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).)
- Change in blood cholesterol levels over acute trial period(Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).)
- Change in blood high-density lipoprotein-cholesterol levels over acute trial period(Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).)
- Stool assessment(Baseline and post-intervention (at 3 weeks))
- Sleep quality assessment(Baseline and post-intervention (at 3 weeks))
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore