Aging, Blood Glucose, Gastrointestinal Microbiome, Microbiota
Conditions
Keywords
Okara, Soybean pulp, Soybean, Fibre, Gut microbiome, Microbiota, Gastrointestinal microbiome, Glycemic, Glycaemic, Middle-aged and older adults, Singapore
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOkara biscuits
Consumption of okara-enriched biscuits together with habitual diet.
DIETARY_SUPPLEMENTBio-okara biscuits
Consumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara.
DIETARY_SUPPLEMENTControl biscuits
Consumption of control biscuits together with habitual diet.
Sponsors
Ministry of Education, Singapore
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Primary investigator of the study will be blinded in this intervention trial through blinding of the intervention allocation to subjects.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to give an informed consent 2. Age 50 to 75 years 3. Willing to follow the study procedures
Exclusion criteria
All subjects meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood amino acid 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). | Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| Change in serum short chain fatty acids (SCFA) before and after a 3 week intervention. | 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 fecal bile acids before and after a 3 week intervention. | 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 serum zonulin before and after a 3 week intervention. | 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 blood glucose levels before and after a 3 week intervention. | 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 blood insulin levels before and after a 3 week intervention. | 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 triglyceride levels before and after a 3 week intervention. | 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 blood cholesterol levels before and after a 3 week intervention. | 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. | 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 high-density lipoprotein-cholesterol levels before and after a 3 week intervention. | 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. |
| Change in blood glucose 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). | Glucose levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| Change in blood insulin 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). | 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 | 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 gut microbiome composition before and after a 3 week intervention. | 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 fecal short chain fatty acids (SCFA) before and after a 3 week intervention. | Baseline and post-intervention (at 3 weeks) | SCFA will be determined via fecal samples of subjects at baseline and after each intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anthropometric measurements | Baseline and post-intervention (at 3 weeks) | Waist circumference |
| Dietary assessment | Baseline and post-intervention (at 3 weeks) | Dietary questionnaires (3-day food record) |
| Stool assessment | Baseline and post-intervention (at 3 weeks) | 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. |
| Sleep quality assessment | Baseline and post-intervention (at 3 weeks) | 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. |
| Cognitive assessment | Baseline and post-intervention (at 3 weeks) | Montreal cognitive assessment |
| Appetite assessment | Baseline and post-intervention (at 3 weeks) | Visual analogue scale, with unit of measure being units on a scale |
| 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). | Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| 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). | Total triglyceride levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| 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). | Total cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| 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). | Low-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| 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). | High-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention |
| Change in blood pressure | Baseline and post-intervention (at 3 weeks) | Blood pressure |
Countries
Singapore
Outcome results
None listed