Low Glycemic Index (GI) FoodNCT06710743
Determination of the Glycemic Index Values of 10 Cereal-based Products
A study testing Glucose solution Day 1, Day 8, and Day 15 and Food (cereal). Ten different cereals served once each in people with Low Glycemic Index (GI) Food and Pre Diabetes, run by PepsiCo Global R&D at 1 site in Australia.
Trial summary
To determine the Glycemic index values for 10 cereal-based products Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Glycemic Index (GI) Food, Pre Diabetes, Diabetes
- What is being tested?
- Glucose solution Day 1, Day 8, and Day 15 and Food (cereal). Ten different cereals served once each
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2024to 27 Sep 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 healthy participants, male and female (non-pregnant, non-lactating) of mixed ethnicity, aged between 18 - 65 y
- BMI: 18 - 25.0 kg/m2 (bounds included)
- Non smokers
- Normal glucose tolerance (assessed by 50 gram oral glucose tolerance test performed within the last 30 days: fasting <6 mM, 2 hr glucose <7.8 mM)
- Stable weight and dietary habits. Normal eating patterns and no history of eating disorders or recent dieting
- Normal sleep patterns (ie. at least 6 hours of sleep per night)
- The participants are required to avoid alcohol and unusual levels of food intake and physical activity for the 24 hours before each test session.
- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Who cannot join
- Food allergy or intolerance to the study ingredients (eg. gluten, etc.)
- Regularly taking prescription medication other than standard contraceptive medication
- Taking any medications known to affect glucose tolerance (eg. acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis)
- Suffering from any illness or disease
- Following a restricted diet
- Smokers
Show all 10Show fewer
- Eating disorders
- Abnormal glucose tolerance or known history of diabetes mellitus.
- Individuals currently participating in other acute metabolic studies
- Failure to meet any one of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sydney University's Glycemic Index Research Service (SUGiRS)
Sydney, New South Wales, 2006
About this study
To determine the Glycemic index values for 10 cereal-based products
Read the detailed description
To determine the Glycemic index values for 10 cereal-based products per international standard (ISO26642:2010) for glycemic index determination.
- Conditions
- Low Glycemic Index (GI) Food, Pre Diabetes, Diabetes
- Being tested
- Glucose solution Day 1, Day 8, and Day 15, Food (cereal). Ten different cereals served once each
- Keywords
- Low GI food, glycemic index, cereal, carbohydrate, glucose
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose solution Day 1, Day 8, and Day 15Other
Glucodin powder diluted with water
Food (cereal). Ten different cereals served once eachOther
Variety of cooked or flake cereal
| Study group | Role | What they receive |
|---|---|---|
| Reference food | Active comparator | Glucodin powder solution Receives: Other: Glucose solution Day 1, Day 8, and Day 15 |
| Food 1 | Experimental | Quaker Whole Oats Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 2 | Experimental | Quaker Quick Cooking White Oats Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 3 | Experimental | Saffola Oats Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 4 | Experimental | Quaker Oats Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 5 | Experimental | Quaker Oats Multigrain Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 6 | Experimental | Ragi Flakes Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 7 | Experimental | Bajra Flakes Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 8 | Experimental | Jowar Flakes Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 9 | Experimental | Maltabella Receives: Other: Food (cereal). Ten different cereals served once each |
| Food 10 | Experimental | FutureLife Smart + White Oats Receives: Other: Food (cereal). Ten different cereals served once each |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index (GI) values
Comparison of Glycemic index (GI) values of 10 different cereal-based products and the reference food (glucose solution assigned GI=100 by definition)
Measured: Two hour test session per visit. Visits must be at least two days apart. Including Screening, the study duration is approximately four to eleven weeks depending on whether participants are available to be tested one, two or three times per week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jul 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Glycemic Index (GI) FoodStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richa Bharti, MS, Principal investigator, PepsiCo R&D Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710743
- Sponsor's protocol ID
- PEP-2402
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycemic Index Values of 10 Cereal-based Products
- ClinicalTrials.gov ID
- NCT06710743
- Acronym / sponsor ID
- PEP-2402
- Conditions
- Low Glycemic Index (GI) Food, Pre Diabetes, Diabetes
- Keywords
- Low GI food, glycemic index, cereal, carbohydrate, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 29 Nov 2024 (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.
To determine the Glycemic index values for 10 cereal-based products
Detailed description
To determine the Glycemic index values for 10 cereal-based products per international standard (ISO26642:2010) for glycemic index determination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Reference food | Active comparator | Other: Glucose solution Day 1, Day 8, and Day 15Glucodin powder solution |
| Food 1 | Experimental | Other: Food (cereal). Ten different cereals served once eachQuaker Whole Oats |
| Food 2 | Experimental | Other: Food (cereal). Ten different cereals served once eachQuaker Quick Cooking White Oats |
| Food 3 | Experimental | Other: Food (cereal). Ten different cereals served once eachSaffola Oats |
| Food 4 | Experimental | Other: Food (cereal). Ten different cereals served once eachQuaker Oats |
| Food 5 | Experimental | Other: Food (cereal). Ten different cereals served once eachQuaker Oats Multigrain |
| Food 6 | Experimental | Other: Food (cereal). Ten different cereals served once eachRagi Flakes |
| Food 7 | Experimental | Other: Food (cereal). Ten different cereals served once eachBajra Flakes |
| Food 8 | Experimental | Other: Food (cereal). Ten different cereals served once eachJowar Flakes |
| Food 9 | Experimental | Other: Food (cereal). Ten different cereals served once eachMaltabella |
| Food 10 | Experimental | Other: Food (cereal). Ten different cereals served once eachFutureLife Smart + White Oats |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 10 healthy participants, male and female (non-pregnant, non-lactating) of mixed ethnicity, aged between 18 - 65 y
- BMI: 18 - 25.0 kg/m2 (bounds included)
- Non smokers
- Normal glucose tolerance (assessed by 50 gram oral glucose tolerance test performed within the last 30 days: fasting <6 mM, 2 hr glucose <7.8 mM)
- Stable weight and dietary habits. Normal eating patterns and no history of eating disorders or recent dieting
Key exclusion criteria (10 listed)
- Food allergy or intolerance to the study ingredients (eg. gluten, etc.)
- Regularly taking prescription medication other than standard contraceptive medication
- Taking any medications known to affect glucose tolerance (eg. acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis)
- Suffering from any illness or disease
- Following a restricted diet
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 |
|---|---|---|
| Glucose solution Day 1, Day 8, and Day 15Glucodin powder diluted with water | Other | Reference food |
| Food (cereal). Ten different cereals served once eachVariety of cooked or flake cereal | Other | Food 1, Food 10, Food 2, Food 3, Food 4, Food 5, Food 6, Food 7, Food 8, Food 9 |
Primary outcome
Glycemic index (GI) values
Time frame: Two hour test session per visit. Visits must be at least two days apart. Including Screening, the study duration is approximately four to eleven weeks depending on whether participants are available to be tested one, two or three times per week.
Comparison of Glycemic index (GI) values of 10 different cereal-based products and the reference food (glucose solution assigned GI=100 by definition)
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 29 Nov 2024.
- Individual participant dataSharing planned: No
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.
Richa Bharti, MS principal investigator
PepsiCo R&D Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose solution Day 1, Day 8, and Day 15 and Food (cereal). Ten different cereals served once each in people with Low Glycemic Index (GI) Food and Pre Diabetes, run by PepsiCo Global R&D 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 8 inclusion and 10 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 29 Nov 2024. 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 index (GI) values (time frame: Two hour test session per visit. Visits must be at least two days apart. Including Screening, the study duration is approximately four to eleven weeks depending on whether participants are available to be tested one, two or three times per week.). 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 29 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.