Metabolism and Nutrition DisordersNCT02538640
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
A study testing High-SDS biscuit and Low-SDS extruded cereals in people with Metabolism and Nutrition Disorders, run by Mondelēz International, Inc. at 1 site in Australia.
Trial summary
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorders
- What is being tested?
- High-SDS biscuit and Low-SDS extruded cereals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2015to Oct 2015
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-45 years.
- Non-smoker.
- BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
- Ethnicity. Subjects should have the closest characteristics compared to the American population. Not less than 75% but not more than 90% of the subjects should be Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent. The remaining subjects will be from other ethnic groups except from Australian Aborigines.
- Healthy subjects with:
- Normal glucose tolerance (fasting blood glucose < 6.0 mmol/L during the first test session and results of oral glucose tolerance test conducted within the last 30 days within recommendations (fasting blood glucose < 6.1 mmol/L, 120 minute glucose < 8.9 mmol/L))
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- Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol);
- Normal systolic blood pressure (100-150 mmHg);
- Normal diastolic blood pressure (60-90 mmHg);
- Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).
- Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
- Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week)
- Able to fast for at least 10 hours the night before each test session
- Able to refrain from eating legumes and drinking alcohol the day before each test session.
- Subject covered by social security or covered by a similar system
- Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely tointerfere with metabolism or dietary habits
- Subject having given written consent to take part in the study.
Who cannot join
- Following a restrictive diet.
- Family history of Diabetes Mellitus or obesity
- Suffering from any clinical, physical or mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
- Subject from the Australian Aboriginal ethnicity.
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- Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
- Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
- Subject having taken part in another clinical trial within the last week.
- Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
- Subject undergoing general anaesthesia in the month prior to inclusion.
- Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
Trial locations and contacts
1 site in 1 country.
About this study
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
Read the detailed description
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
- Conditions
- Metabolism and Nutrition Disorders
- Being tested
- High-SDS biscuit, Low-SDS extruded cereals
- Keywords
- Nutrition, glycemic response, cereal products
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-SDS biscuitOther
Consumption of the high-SDS product (50g) alone with a glass of water
Low-SDS extruded cerealsOther
Consumption of the low-SDS product (42g) alone with a glass of water
| Study group | Role | What they receive |
|---|---|---|
| High-SDS biscuit | Experimental | 50 g of moist biscuit with high-SDS content and low GI with a glass of water Receives: Other: High-SDS biscuit |
| Low-SDS breakfast cereals | Active comparator | 42 g of extruded cereals with no SDS and medium to high GI with a glass of water Receives: Other: Low-SDS extruded cereals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Response over 2 hours
iAUC of glycemia over 2 first hours of postprandial period
Measured: 2 hours
Secondary outcomes (6)
Glycemic response
Postprandial changes in glycaemia over 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC[180-240]) following the intake of the test products will be analysed
Measured: 4 hours
Blood glucose kinetic
Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)
Measured: 4 hours
Insulinemic response
Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC [180-240]) following the intake of the test products will be analysed.
Measured: 4 hours
Blood insulin kinetic
Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)
Measured: 4 hours
Blood glucose peak
Maximal concentration and delta between maximum concentration and baseline value for glycemia
Measured: 4 hours
Blood insulin peak
Maximal concentration and delta between maximum concentration and baseline value for insulinemia
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism and Nutrition DisordersStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Sydney
- Responsible party
- Sponsor
- Investigators
- Jennie Brand Miller, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538640
- Sponsor's protocol ID
- KBE040
- Status last verified
- Oct 2015
- First submitted
- 31 Aug 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
- ClinicalTrials.gov ID
- NCT02538640
- Acronym / sponsor ID
- KBE040
- Conditions
- Metabolism and Nutrition Disorders
- Keywords
- Nutrition, glycemic response, cereal products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Sydney
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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 is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
Detailed description
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-SDS biscuit | Experimental | Other: High-SDS biscuit50 g of moist biscuit with high-SDS content and low GI with a glass of water |
| Low-SDS breakfast cereals | Active comparator | Other: Low-SDS extruded cereals42 g of extruded cereals with no SDS and medium to high GI with a glass of water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Aged between 18-45 years.
- Non-smoker.
- BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
- Ethnicity. Subjects should have the closest characteristics compared to the American population. Not less than 75% but not more than 90% of the subjects should be Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent. The remaining subjects will be from other ethnic groups except from Australian Aborigines.
- Healthy subjects with:
Key exclusion criteria (12 listed)
- Following a restrictive diet.
- Family history of Diabetes Mellitus or obesity
- Suffering from any clinical, physical or mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
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 |
|---|---|---|
| High-SDS biscuitConsumption of the high-SDS product (50g) alone with a glass of water | Other | High-SDS biscuit |
| Low-SDS extruded cerealsConsumption of the low-SDS product (42g) alone with a glass of water | Other | Low-SDS breakfast cereals |
Primary outcome
Glycemic Response over 2 hours
Time frame: 2 hours
iAUC of glycemia over 2 first hours of postprandial period
6 secondary outcomes
Glycemic response
Time frame: 4 hours
Blood glucose kinetic
Time frame: 4 hours
Insulinemic response
Time frame: 4 hours
Blood insulin kinetic
Time frame: 4 hours
Blood glucose peak
Time frame: 4 hours
Blood insulin peak
Time frame: 4 hours
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 2 Nov 2015.
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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.
Jennie Brand Miller principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-SDS biscuit and Low-SDS extruded cereals in people with Metabolism and Nutrition Disorders, run by Mondelēz International, Inc. at 1 site in Australia.
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 17 inclusion and 12 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 2 Nov 2015. 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 Australia. 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?
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?
Glycemic Response over 2 hours (time frame: 2 hours). 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 2 Nov 2015.