Clinical trial NCT06710743: Determination of the Glycemic Index Values of 10 Cereal-based Products
Official title: Determination of the Glycemic Index Values of 10 Cereal-based Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Glycemic Index (GI) Food
Pre Diabetes
Diabetes
Keywords: Low GI food
glycemic index
cereal
carbohydrate
glucose
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Glycemic index (GI) values
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney University's Glycemic Index Research Service (SUGiRS)
state: New South Wales
Study officials:
affiliation: PepsiCo R&D Life Sciences
name: Richa Bharti, MS
role: PRINCIPAL_INVESTIGATOR
References: