HealthyNCT04930250
Effect of Various Processed Oat Bran in a Beverage Matrix on Glycaemic Health
A study testing Beverage powder with 12% oat bran processed with method A, Beverage powder with 12% oat bran processed with method B and Beverage powder with 12% oat bran processed with method C in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.
Trial summary
Whilst a cause-and-effect relationship between consumption of oat ß-glucans and reduction in PPGR has been demonstrated, little is understood about its: Application to liquid matrices: There are few studies which looked into the effect of a dose of ß-glucan applicable to beverages. Read more about this study
- Who is it for?
- Ages 24 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Beverage powder with 12% oat bran processed with method A, Beverage powder with 12% oat bran processed with method B and Beverage powder with 12% oat bran processed with method C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Jul 2021to 21 Dec 2021
- 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 24 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants, age between 24 and 39 years
- Healthy individuals with no comorbidities or on regular medication
- BMI between 18.5-25 kg/m2
- Able to understand and willing to sign an informed consent form in English
- Regularly consume breakfast
- Able and willing to consume 330ml of liquid in 10 minutes
- For female participants, have a regular menstrual cycle
Who cannot join
- Known food allergies or intolerances specifically to gluten, milk, lactose or any grains
- Known drug allergies specifically paracetamol
- Known sensitivity or has had an adverse reaction to paracetamol and non-steroidal anti-inflammatory drugs (NSAID) in the past
- Individuals with regular prescriptions or regularly consume medication (at least once a month), including alternative medicine (e.g. traditional Chinese medicine)
- Had been diagnosed or with a history of any metabolic disease or disorders, including diabetes, gestational diabetes and hypertension
- Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
Show all 18Show fewer
- Had been hospitalised in the 3 months prior to the study.
- Pregnant or lactating women, or planning to conceive in the next 3 months
- Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.
- Smokers
- Poor peripheral venous access based on past experiences with blood draw
- Significant change in weight (≥ 3 kg body weight) in the past 3 months
- Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
- Currently on a specialised diet e.g. vegetarian, vegan, weight loss plan, high protein diet
- Unwilling to refrain from consuming fibre or prebiotic supplements, high fibre ingredients and more than 5 servings of fruits and vegetables per day over the length of the study.
- Has donated blood in the past one month
- Hierarchical link with the research team members
- Participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Controlled, Crossover Study to Evaluate the Acute Effect on Glycemic Response and Related Biomarkers When Replacing Rapidly Digested Carbohydrates by β-glucan-rich Oat Bran Processed in Different Conditions
Whilst a cause-and-effect relationship between consumption of oat ß-glucans and reduction in PPGR has been demonstrated, little is understood about its:
- Application to liquid matrices: There are few studies which looked into the effect of a dose of ß-glucan applicable to beverages. Previous studies have explored oat ß-glucan doses between 2g to 13g per serving of test product (Note: the oat ß-glucan dose for the proposed trial is <2g).
- Impact following processing: Collectively, oat processing, ß-glucan structure and its physiological impact on PPGR are closely linked. Some studies have investigated the effect of oat processing or dosage on PPGR, but to our knowledge, no study has systematically characterised the effect of processing on oat structure, and clinically measured its subsequent impact on PPGR.
Read the detailed description
The proposed study is a randomised, double blind, controlled, crossover trial to investigate the postprandial effects on glycemic response and related biomarkers/biological surrogates in five test product beverages:
This study will investigate the post-prandial effects of five test products, including two controls:
- Beverage powder with 12% oat bran processed with method A (Test Product: TP-1)
- Beverage powder with 12% oat bran processed with method B (Test Product: TP-2)
- Beverage powder with 12% oat bran processed with method C (Test Product: TP-3)
- Beverage powder with 12% minimally-processed oat bran (Positive Control) (Test Product: TP-PC)
- Beverage powder without oat bran (Negative Control) (Test Product: TP-NC)
- Conditions
- Healthy
- Being tested
- Beverage powder with 12% oat bran processed with method A, Beverage powder with 12% oat bran processed with method B, Beverage powder with 12% oat bran processed with method C, Placebo Comparator: Minimally-processed oat bran (Positive Control), Placebo Comparator: Readily-digestible carbohydrate (negative control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage powder with 12% oat bran processed with method AOther
50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
Beverage powder with 12% oat bran processed with method BOther
50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
Beverage powder with 12% oat bran processed with method COther
50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
Placebo Comparator: Minimally-processed oat bran (Positive Control)Other
50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
Placebo Comparator: Readily-digestible carbohydrate (negative control)Other
50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
| Study group | Role | What they receive |
|---|---|---|
| Oat bran fibre processed with method A | Experimental | Beverage powder with 12% oat bran processed with method A Receives: Other: Beverage powder with 12% oat bran processed with method A |
| Oat bran fibre processed with method B | Experimental | Beverage powder with 12% oat bran processed with method B Receives: Other: Beverage powder with 12% oat bran processed with method B |
| Oat bran fibre processed with method C | Experimental | Beverage powder with 12% oat bran processed with method C Receives: Other: Beverage powder with 12% oat bran processed with method C |
| Minimally-processed oat bran (positive control) | Active comparator | Beverage powder with minimally-processed oat bran (Positive Control) Receives: Other: Placebo Comparator: Minimally-processed oat bran (Positive Control) |
| Readily-digestible carbohydrate (negative control) | Placebo comparator | Beverage powder with readily digestible carbohydrate (Negative Control) Receives: Other: Placebo Comparator: Readily-digestible carbohydrate (negative control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC)
Postprandial glycemic response reflected by 3-hour area under the plasma concentration versus time curve (AUC) assessed over all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Measured: through study completion, an average of 7 months
Postprandial glycemic response - Peak Plasma Concentration (Cmax)
Postprandial glycemic response by the peak plasma concentration (Cmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Measured: through study completion, an average of 7 months
Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax)
Postprandial glycemic response reflected by time to achieve the peak plasma concentration (Tmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Measured: through study completion, an average of 7 months
Secondary outcomes (7)
Postprandial insulin response (PPIR)
PPIR over a 3-hour period
Measured: through study completion, an average of 7 months
Postprandial blood gastric inhibitory polypeptide (GIP)
Postprandial blood GIP over a 3-hour period
Measured: through study completion, an average of 7 months
Postprandial blood glucagon-like peptide 1 (GLP-1)
Postprandial blood GLP-1 over a 3-hour period
Measured: through study completion, an average of 7 months
Gastric emptying rate
Gastric emptying rate measured through postprandial blood paracetamol concentration over a 4-hour period
Measured: through study completion, an average of 7 months
Satiety
Satiety assessed via a Visual Analogue Scale questionnaire from 0-10 over a 4-hour period, with 0 being least satiated and 10 being most satiated
Measured: through study completion, an average of 7 months
Gastrointestinal comfort
Gastrointestinal comfort assessed via a Visual Analogue Scale questionnaire from 0-10 over a 4-hour period, with 0 being lowest discomfort and 10 being greatest discomfort
Measured: through study completion, an average of 7 months
Ingredient fermentability by colonic bacteria
Fermentability by colonic bacteria will be assessed via breath hydrogen and methane (ppm) levels over a 4-hour period
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start19 Jul 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised controlled, double-blind, full crossover study conducted in an acute setting. 20 subjects will receive 5 test products, over 5 separate test visits in a crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930250
- Sponsor's protocol ID
- 20.13.DAI
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Controlled, Crossover Study to Evaluate the Acute Effect on Glycemic Response and Related Biomarkers When Replacing Rapidly Digested Carbohydrates by β-glucan-rich Oat Bran Processed in Different Conditions
- ClinicalTrials.gov ID
- NCT04930250
- Acronym / sponsor ID
- 20.13.DAI
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, National University of Singapore
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 18 Jun 2021 (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.
Whilst a cause-and-effect relationship between consumption of oat ß-glucans and reduction in PPGR has been demonstrated, little is understood about its:
- Application to liquid matrices: There are few studies which looked into the effect of a dose of ß-glucan applicable to beverages. Previous studies have explored oat ß-glucan doses between 2g to 13g per serving of test product (Note: the oat ß-glucan dose for the proposed trial is <2g).
- Impact following processing: Collectively, oat processing, ß-glucan structure and its physiological impact on PPGR are closely linked. Some studies have investigated the effect of oat processing or dosage on PPGR, but to our knowledge, no study has systematically characterised the effect of processing on oat structure, and clinically measured its subsequent impact on PPGR.
Detailed description
The proposed study is a randomised, double blind, controlled, crossover trial to investigate the postprandial effects on glycemic response and related biomarkers/biological surrogates in five test product beverages:
This study will investigate the post-prandial effects of five test products, including two controls:
- Beverage powder with 12% oat bran processed with method A (Test Product: TP-1)
- Beverage powder with 12% oat bran processed with method B (Test Product: TP-2)
- Beverage powder with 12% oat bran processed with method C (Test Product: TP-3)
- Beverage powder with 12% minimally-processed oat bran (Positive Control) (Test Product: TP-PC)
- Beverage powder without oat bran (Negative Control) (Test Product: TP-NC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomised controlled, double-blind, full crossover study conducted in an acute setting. 20 subjects will receive 5 test products, over 5 separate test visits in a crossover design.
| Arm | Type | Receives |
|---|---|---|
| Oat bran fibre processed with method A | Experimental | Other: Beverage powder with 12% oat bran processed with method ABeverage powder with 12% oat bran processed with method A |
| Oat bran fibre processed with method B | Experimental | Other: Beverage powder with 12% oat bran processed with method BBeverage powder with 12% oat bran processed with method B |
| Oat bran fibre processed with method C | Experimental | Other: Beverage powder with 12% oat bran processed with method CBeverage powder with 12% oat bran processed with method C |
| Minimally-processed oat bran (positive control) | Active comparator | Other: Placebo Comparator: Minimally-processed oat bran (Positive Control)Beverage powder with minimally-processed oat bran (Positive Control) |
| Readily-digestible carbohydrate (negative control) | Placebo comparator | Other: Placebo Comparator: Readily-digestible carbohydrate (negative control)Beverage powder with readily digestible carbohydrate (Negative Control) |
Who may qualify
- Ages
- 24 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female participants, age between 24 and 39 years
- Healthy individuals with no comorbidities or on regular medication
- BMI between 18.5-25 kg/m2
- Able to understand and willing to sign an informed consent form in English
- Regularly consume breakfast
Key exclusion criteria (18 listed)
- Known food allergies or intolerances specifically to gluten, milk, lactose or any grains
- Known drug allergies specifically paracetamol
- Known sensitivity or has had an adverse reaction to paracetamol and non-steroidal anti-inflammatory drugs (NSAID) in the past
- Individuals with regular prescriptions or regularly consume medication (at least once a month), including alternative medicine (e.g. traditional Chinese medicine)
- Had been diagnosed or with a history of any metabolic disease or disorders, including diabetes, gestational diabetes and hypertension
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 |
|---|---|---|
| Beverage powder with 12% oat bran processed with method A50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. | Other | Oat bran fibre processed with method A |
| Beverage powder with 12% oat bran processed with method B50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. | Other | Oat bran fibre processed with method B |
| Beverage powder with 12% oat bran processed with method C50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. | Other | Oat bran fibre processed with method C |
| Placebo Comparator: Minimally-processed oat bran (Positive Control)50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. | Other | Minimally-processed oat bran (positive control) |
| Placebo Comparator: Readily-digestible carbohydrate (negative control)50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. | Other | Readily-digestible carbohydrate (negative control) |
Primary outcome
Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC)
Time frame: through study completion, an average of 7 months
Postprandial glycemic response reflected by 3-hour area under the plasma concentration versus time curve (AUC) assessed over all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Postprandial glycemic response - Peak Plasma Concentration (Cmax)
Time frame: through study completion, an average of 7 months
Postprandial glycemic response by the peak plasma concentration (Cmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax)
Time frame: through study completion, an average of 7 months
Postprandial glycemic response reflected by time to achieve the peak plasma concentration (Tmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
7 secondary outcomes
Postprandial insulin response (PPIR)
Time frame: through study completion, an average of 7 months
Postprandial blood gastric inhibitory polypeptide (GIP)
Time frame: through study completion, an average of 7 months
Postprandial blood glucagon-like peptide 1 (GLP-1)
Time frame: through study completion, an average of 7 months
Gastric emptying rate
Time frame: through study completion, an average of 7 months
Satiety
Time frame: through study completion, an average of 7 months
Gastrointestinal comfort
Time frame: through study completion, an average of 7 months
Ingredient fermentability by colonic bacteria
Time frame: through study completion, an average of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage powder with 12% oat bran processed with method A, Beverage powder with 12% oat bran processed with method B and Beverage powder with 12% oat bran processed with method C in people with Healthy, run by Société des Produits Nestlé (SPN) 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 22 Sep 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC) (time frame: through study completion, an average of 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2022.