NCT03978104

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

May 24, 2019

Last Update Submit

March 23, 2022

Conditions

MicrobiotaGastrointestinal MicrobiomeBlood GlucoseAging

Keywords

OkaraSoybean pulpSoybeanFibreGut microbiomeMicrobiotaGastrointestinal microbiomeGlycemicGlycaemicMiddle-aged and older adultsSingapore

Outcome Measures

Primary Outcomes (15)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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 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 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 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 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

    Baseline and post-intervention (at 3 weeks)

  • Change in anthropometric measurements

    Baseline and post-intervention (at 3 weeks)

  • Change in anthropometric measurements

    Baseline and post-intervention (at 3 weeks)

  • Change in anthropometric measurements

    Baseline

  • Dietary assessment

    Baseline and post-intervention (at 3 weeks)

  • +11 more secondary outcomes

Study Arms (3)

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.

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.

Dietary Supplement: Bio-okara biscuits

Control biscuits

EXPERIMENTAL

Subjects will consume their habitual diet with daily control biscuit consumption for 21 days.

Dietary Supplement: Control biscuits

Interventions

Okara biscuitsDIETARY_SUPPLEMENT

Consumption of okara-enriched biscuits together with habitual diet.

Okara biscuits
Bio-okara biscuitsDIETARY_SUPPLEMENT

Consumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara.

Also known as: Fermented okara biscuits
Bio-okara biscuits
Control biscuitsDIETARY_SUPPLEMENT

Consumption of control biscuits together with habitual diet.

Control biscuits

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to give an informed consent
  • Age 50 to 75 years
  • Willing to follow the study procedures

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science and Technology; National University of Singapore

Singapore, 117546, Singapore

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 18636739BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 36040444DERIVED

Study Officials

  • Jung Eun Kim

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Primary investigator of the study will be blinded in this intervention trial through blinding of the intervention allocation to subjects.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 24, 2019

First Posted

June 6, 2019

Study Start

November 1, 2019

Primary Completion

September 28, 2020

Study Completion

September 1, 2022

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Electronic data with any identifiable participant information will be de-identified prior to statistical analysis.

Locations

SG(1)