Clinical trial NCT03978104: Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore
Official title: Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbiota
Gastrointestinal Microbiome
Blood Glucose
Aging
Keywords: Okara
Soybean pulp
Soybean
Fibre
Gut microbiome
Microbiota
Gastrointestinal microbiome
Glycemic
Glycaemic
Middle-aged and older adults
Singapore
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Singapore
First posted: 2019-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 exclusion criteria at baseline will be excluded from participation

1. Significant change in weight (≥ 3 kg body weight) during the past 3 months
2. Allergy to soy-based products
3. Acute illness at the study baseline
4. Exercising vigorously over the past 3 months
5. Following any restricted diet (e.g. vegetarian)
6. Smoking
7. Have a daily intake of more than 2 alcoholic drinks per day
8. Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation
9. Taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, probiotic supplement etc.)
10. Pregnant, lactating, or planning pregnancy in the next 6 months
11. Insufficient venous access to allow the blood collection
12. Very high intake of fibre/ vegetables on a daily basis

Primary outcomes:
measure: Change in gut microbiome composition before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in fecal short chain fatty acids (SCFA) before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in serum short chain fatty acids (SCFA) before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in fecal bile acids before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in serum zonulin before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood glucose levels before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood insulin levels before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood triglyceride levels before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood cholesterol levels before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood low-density lipoprotein-cholesterol levels before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood high-density lipoprotein-cholesterol levels before and after a 3 week intervention.
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood glucose levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood insulin levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood short-chain fatty acids levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood amino acid levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in anthropometric measurements
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in anthropometric measurements
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in anthropometric measurements
timeFrame: Baseline
measure: Dietary assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Stool assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Stool assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Sleep quality assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Sleep quality assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Cognitive assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Appetite assessment
timeFrame: Baseline and post-intervention (at 3 weeks)
measure: Change in blood amino acids levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood triglyceride levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood cholesterol levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood low-density lipoprotein-cholesterol levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
measure: Change in blood high-density lipoprotein-cholesterol levels over acute trial period
timeFrame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Department of Food Science and Technology; National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Jung Eun Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Lu, 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.
citation: Lee 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.