NCT03978104

Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Microbiota
• Gastrointestinal Microbiome
• Blood Glucose
• Aging

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Okara biscuits	Consumption of okara-enriched biscuits together with habitual diet.
DIETARY_SUPPLEMENT	Bio-okara biscuits	Consumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara.
DIETARY_SUPPLEMENT	Control biscuits	Consumption of control biscuits together with habitual diet.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-09-28
• Completion: 2022-09-01
• First posted: 2019-06-06
• Last updated: 2022-03-24

Locations

1 site across 1 country: Singapore