NCT02692144

Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals

Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals: A Randomized, Cross-over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: PepsiCo Global R&D · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made through a proprietary baking process combined with slow digestible carbohydrates and fiber will elicit lower postprandial blood glucose and insulin responses than a Control-cluster made from general processing procedure and with typical ingredients commonly used in commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the Test-cluster contains \~30% less available-carbohydrate (24g) than the Control (33g), the postprandial responses elicited by the Test-cluster was also compared with those after a portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25 healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with fasting serum glucose \<7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained similar amounts of total carbohydrates, protein, fat and energy content. Each serving of Test-cluster and White-bread had equivalent amount of 24g available carbohydrate. On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal. Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60, 90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample. During the 4hr of the test, participants remained seated quietly. After the last blood sample participants were offered a snack and then allowed to leave.

Conditions

• Peak Rise of Blood Glucose

Interventions

Type	Name	Description
OTHER	Test Cluster	Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2016-02-25
• Last updated: 2018-02-05