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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20
Consumption of okara-enriched biscuits together with habitual diet.
Consumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara.
Consumption of control biscuits together with habitual diet.
Department of Food Science and Technology; National University of Singapore
Singapore, Singapore
Change in gut microbiome composition before and after a 3 week intervention.
Gut microbiome composition will be determined via fecal samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in fecal short chain fatty acids (SCFA) before and after a 3 week intervention.
SCFA will be determined via fecal samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in serum short chain fatty acids (SCFA) before and after a 3 week intervention.
SCFA will be determined via serum samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in fecal bile acids before and after a 3 week intervention.
Bile acids will be determined via serum samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in serum zonulin before and after a 3 week intervention.
Serum zonulin will be determined via serum samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood glucose levels before and after a 3 week intervention.
Glucose levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood insulin levels before and after a 3 week intervention.
Insulin levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood triglyceride levels before and after a 3 week intervention.
Total triglyceride levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood cholesterol levels before and after a 3 week intervention.
Total cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood low-density lipoprotein-cholesterol levels before and after a 3 week intervention.
Low-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood high-density lipoprotein-cholesterol levels before and after a 3 week intervention.
High-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood glucose levels over acute trial period
Glucose levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: 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 insulin levels over acute trial period
Insulin levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: 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 short-chain fatty acids levels over acute trial period
Short-chain fatty acids levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: 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 acid levels over acute trial period
Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Change in blood pressure
Blood pressure
Time frame: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Waist circumference
Time frame: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Weight
Time frame: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Height
Time frame: Baseline
Dietary assessment
Dietary questionnaires (3-day food record)
Time frame: Baseline and post-intervention (at 3 weeks)
Stool assessment
Stool sampling questionnaire will be completed by subjects, which notes down food or alcohol consumed over the past 24 hours prior to collection, any discomfort, pain or bloating, flatulence, noticable changes in stool frequency or consistency, any blood in stool and any type of medication consumed over the past 3 months.
Time frame: Baseline and post-intervention (at 3 weeks)
Stool assessment
Bristol stool chart (Ranging from Type 1 to Type 7, with Type 3 or 4 being ideal.
Time frame: Baseline and post-intervention (at 3 weeks)
Sleep quality assessment
Pittsburgh sleep quality index questionnaire, with 7 different components assessing sleep and each component making up a minimum or 0 and maximum of 3 points. The full scale ranges from 0 to 21, with a lower score indicative of a better quality of sleep.
Time frame: Baseline and post-intervention (at 3 weeks)
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Sleep quality assessment
Sleep evaluation questionnaire (survey) to assess eligibility for studies with sleep involved
Time frame: Baseline and post-intervention (at 3 weeks)
Cognitive assessment
Montreal cognitive assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Appetite assessment
Visual analogue scale, with unit of measure being units on a scale
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood amino acids levels over acute trial period
Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Change in blood triglyceride levels over acute trial period
Total triglyceride levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: 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
Total cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: 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 low-density lipoprotein-cholesterol levels over acute trial period
Low-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: 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
High-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention
Time frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).