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OpenTrials
Completed

NCT Number: NCT06710743

Determination of the Glycemic Index Values of 10 Cereal-based Products

To determine the Glycemic index values for 10 cereal-based products

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sydney University's Glycemic Index Research Service (SUGiRS)

Sydney, New South Wales, 2006, Australia

About this study

To determine the Glycemic index values for 10 cereal-based products per international standard (ISO26642:2010) for glycemic index determination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose solution Day 1, Day 8, and Day 15

Other

Glucodin powder diluted with water

Food (cereal). Ten different cereals served once each

Other

Variety of cooked or flake cereal

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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