MicrobiotaNCT03978104
Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore
A study testing Okara biscuits and Bio-okara biscuits in people with Microbiota and Gastrointestinal Microbiome, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Gastrointestinal Microbiome, Blood Glucose
- What is being tested?
- Okara biscuits and Bio-okara biscuits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2019to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give an informed consent
- Age 50 to 75 years
- Willing to follow the study procedures
Who cannot join
- 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)
Show all 13Show fewer
- Smoking
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Department of Food Science and Technology; National University of Singapore
Singapore, 117546
About this study
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).
Read the 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.
- Conditions
- Microbiota, Gastrointestinal Microbiome, Blood Glucose, Aging
- Being tested
- Okara biscuits, Bio-okara biscuits, Control biscuits
- Keywords
- Okara, Soybean pulp, Soybean, Fibre, Gut microbiome, Microbiota, Gastrointestinal microbiome, Glycemic, Glycaemic, Middle-aged and older adults, Singapore
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Okara biscuitsDietary supplement
Consumption of okara-enriched biscuits together with habitual diet.
Bio-okara biscuitsDietary supplement
Also called Fermented okara biscuits
Consumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara.
Control biscuitsDietary supplement
Consumption of control biscuits together with habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| Okara biscuits | Experimental | Subjects will consume their habitual diet with daily okara biscuit consumption accounting to 20 grams/ day of dry okara powder for 21 days. Receives: Dietary Supplement: Okara biscuits |
| Bio-okara biscuits | Experimental | Subjects will consume their habitual diet with daily bio-okara biscuit consumption accounting to 20 grams/ day of dry bio-okara powder for 21 days. Receives: Dietary Supplement: Bio-okara biscuits |
| Control biscuits | Experimental | Subjects will consume their habitual diet with daily control biscuit consumption for 21 days. Receives: Dietary Supplement: Control biscuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Secondary outcomes (16)
Change in blood pressure
Blood pressure
Measured: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Waist circumference
Measured: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Weight
Measured: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Height
Measured: Baseline
Dietary assessment
Dietary questionnaires (3-day food record)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention (at 3 weeks)
Sleep quality assessment
Sleep evaluation questionnaire (survey) to assess eligibility for studies with sleep involved
Measured: Baseline and post-intervention (at 3 weeks)
Cognitive assessment
Montreal cognitive assessment
Measured: Baseline and post-intervention (at 3 weeks)
Appetite assessment
Visual analogue scale, with unit of measure being units on a scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Nov 2019
- Primary completion28 Sep 2020
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- Jung Eun Kim, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978104
- Sponsor's protocol ID
- S4
- Status last verified
- Mar 2022
- First submitted
- 24 May 2019
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Electronic data with any identifiable participant information will be de-identified prior to statistical analysis.
Publications
Vong, W.C., X.Y. Hua, and S.-Q. Liu, Solid-state fermentation with Rhizopus oligosporus and Yarrowia lipolytica improved nutritional and flavour properties of okara. Lwt, 2018. 90: p. 316-322.
Yogo, T., et al., Influence of Dried Okara-Tempeh on the Composition and Metabolites of Fecal Microbiota in Dogs. International Journal of Applied Research in Veterinary Medicine, 2011. 9(2): p. 176-183.
Jimenez-Escrig A, Tenorio MD, Espinosa-Martos I, Ruperez P. Health-promoting effects of a dietary fiber concentrate from the soybean byproduct okara in rats. J Agric Food Chem. 2008 Aug 27;56(16):7495-501. doi: 10.1021/jf800792y. Epub 2008 Jul 18.
PubMed 18636739Lu, F., Y. Liu, and B. Li, Okara dietary fiber and hypoglycemic effect of okara foods. Bioactive Carbohydrates and Dietary Fibre, 2013. 2(2): p. 126-132.
Lee DPS, Mak IEK, Leong GXY, Liu X, Kim JE. Effect of okara and biovalorised okara consumption on postprandial amino acid response: a crossover randomised controlled trial. Eur J Clin Nutr. 2026 Jun 2. doi: 10.1038/s41430-026-01769-4. Online ahead of print.
PubMed 42230764Lee DPS, Gan AX, Sutanto CN, Toh KQX, Khoo CM, Kim JE. Postprandial glycemic and circulating SCFA concentrations following okara- and biovalorized okara-containing biscuit consumption in middle-aged and older adults: a crossover randomized controlled trial. Food Funct. 2022 Sep 22;13(18):9687-9699. doi: 10.1039/d2fo00526c.
PubMed 36040444
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore
- ClinicalTrials.gov ID
- NCT03978104
- Acronym / sponsor ID
- S4
- Conditions
- Microbiota, Gastrointestinal Microbiome, Blood Glucose, Aging
- Keywords
- Okara, Soybean pulp, Soybean, Fibre, Gut microbiome, Microbiota, Gastrointestinal microbiome, Glycemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Okara biscuits | Experimental | Dietary Supplement: Okara biscuitsSubjects will consume their habitual diet with daily okara biscuit consumption accounting to 20 grams/ day of dry okara powder for 21 days. |
| Bio-okara biscuits | Experimental | Dietary Supplement: Bio-okara biscuitsSubjects will consume their habitual diet with daily bio-okara biscuit consumption accounting to 20 grams/ day of dry bio-okara powder for 21 days. |
| Control biscuits | Experimental | Dietary Supplement: Control biscuitsSubjects will consume their habitual diet with daily control biscuit consumption for 21 days. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to give an informed consent
- Age 50 to 75 years
- Willing to follow the study procedures
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Okara biscuitsConsumption of okara-enriched biscuits together with habitual diet. | Dietary supplement | Okara biscuits |
| Bio-okara biscuitsAlso: Fermented okara biscuitsConsumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara. | Dietary supplement | Bio-okara biscuits |
| Control biscuitsConsumption of control biscuits together with habitual diet. | Dietary supplement | Control biscuits |
Primary outcome
Change in gut microbiome composition before and after a 3 week intervention.
Time frame: 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.
Time frame: 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 serum short chain fatty acids (SCFA) before and after a 3 week intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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).
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 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).
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 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).
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
Time frame: 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
16 secondary outcomes
Change in blood pressure
Time frame: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Time frame: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Time frame: Baseline and post-intervention (at 3 weeks)
Change in anthropometric measurements
Time frame: Baseline
Dietary assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Stool assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Stool assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Sleep quality assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Sleep quality assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Cognitive assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Appetite assessment
Time frame: Baseline and post-intervention (at 3 weeks)
Change in blood amino acids levels over acute trial period
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
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
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
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
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- BackgroundVong, W.C., X.Y. Hua, and S.-Q. Liu, Solid-state fermentation with Rhizopus oligosporus and Yarrowia lipolytica improved nutritional and flavour properties of okara. Lwt, 2018. 90: p. 316-322.
- BackgroundYogo, T., et al., Influence of Dried Okara-Tempeh on the Composition and Metabolites of Fecal Microbiota in Dogs. International Journal of Applied Research in Veterinary Medicine, 2011. 9(2): p. 176-183.
- Background: PubMed 18636739Jimenez-Escrig A, Tenorio MD, Espinosa-Martos I, Ruperez P. Health-promoting effects of a dietary fiber concentrate from the soybean byproduct okara in rats. J Agric Food Chem. 2008 Aug 27;56(16):7495-501. doi: 10.1021/jf800792y. Epub 2008 Jul 18.
- BackgroundLu, F., Y. Liu, and B. Li, Okara dietary fiber and hypoglycemic effect of okara foods. Bioactive Carbohydrates and Dietary Fibre, 2013. 2(2): p. 126-132.
- Derived from this study: PubMed 42230764Lee DPS, Mak IEK, Leong GXY, Liu X, Kim JE. Effect of okara and biovalorised okara consumption on postprandial amino acid response: a crossover randomised controlled trial. Eur J Clin Nutr. 2026 Jun 2. doi: 10.1038/s41430-026-01769-4. Online ahead of print.
- Derived from this study: PubMed 36040444Lee DPS, Gan AX, Sutanto CN, Toh KQX, Khoo CM, Kim JE. Postprandial glycemic and circulating SCFA concentrations following okara- and biovalorized okara-containing biscuit consumption in middle-aged and older adults: a crossover randomized controlled trial. Food Funct. 2022 Sep 22;13(18):9687-9699. doi: 10.1039/d2fo00526c.
- Individual participant dataSharing planned: No. Electronic data with any identifiable participant information will be de-identified prior to statistical analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Eun Kim principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Okara biscuits and Bio-okara biscuits in people with Microbiota and Gastrointestinal Microbiome, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome composition before and after a 3 week intervention. (time frame: Baseline and post-intervention (at 3 weeks)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978104, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.