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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06710743




Registration number
NCT06710743
Ethics application status
Date submitted
25/11/2024
Date registered
29/11/2024

Titles & IDs
Public title
Determination of the Glycemic Index Values of 10 Cereal-based Products
Scientific title
Determination of the Glycemic Index Values of 10 Cereal-based Products
Secondary ID [1] 0 0
PEP-2402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Glycemic Index (GI) Food 0 0
Pre Diabetes 0 0
Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Glucose solution Day 1, Day 8, and Day 15
Other interventions - Food (cereal). Ten different cereals served once each

Active comparator: Reference food - Glucodin powder solution

Experimental: Food 1 - Quaker Whole Oats

Experimental: Food 2 - Quaker Quick Cooking White Oats

Experimental: Food 3 - Saffola Oats

Experimental: Food 4 - Quaker Oats

Experimental: Food 5 - Quaker Oats Multigrain

Experimental: Food 6 - Ragi Flakes

Experimental: Food 7 - Bajra Flakes

Experimental: Food 8 - Jowar Flakes

Experimental: Food 9 - Maltabella

Experimental: Food 10 - FutureLife Smart + White Oats


Other interventions: Glucose solution Day 1, Day 8, and Day 15
Glucodin powder diluted with water

Other interventions: Food (cereal). Ten different cereals served once each
Variety of cooked or flake cereal
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycemic index (GI) values
Timepoint [1] 0 0
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.

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2024
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney University's Glycemic Index Research Service (SUGiRS) - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PepsiCo Global R&D
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richa Bharti, MS
Address 0 0
PepsiCo R&D Life Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06710743