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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Pre Diabetes; Low Glycemic Index (GI) Food
• Intervention / Treatment: Other: Glucose solution Day 1, Day 8, and Day 15; Other: Food (cereal). Ten different cereals served once each

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2006
      • Sydney University's Glycemic Index Research Service (SUGiRS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference food; Glucodin powder solution	Other: Glucose solution Day 1, Day 8, and Day 15; Glucodin powder diluted with water
Experimental: Food 1; Quaker Whole Oats	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 2; Quaker Quick Cooking White Oats	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 3; Saffola Oats	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 4; Quaker Oats	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 5; Quaker Oats Multigrain	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 6; Ragi Flakes	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 7; Bajra Flakes	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 8; Jowar Flakes	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 9; Maltabella	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal
Experimental: Food 10; FutureLife Smart + White Oats	Other: Food (cereal). Ten different cereals served once each; Variety of cooked or flake cereal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Richa Bharti, MS, PepsiCo R&D Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: glycemic index; glucose; carbohydrate; cereal; Low GI food
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: PEP-2402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No