Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact

Diabetes Mellitus Clinical Trial

— Solstice  

Official title:

Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537587
• Other study ID #: GIL-1342
• Secondary ID: PEP-1324
• Status: Completed
• Phase: N/A
• First received: August 28, 2015
• Last updated: August 31, 2015
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Glycemic Index Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine the effect of changing the amounts of resistant starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy bars. The investigators also compared the glucose and insulin responses to the rates at which the food bars were digested in-vitro (in the test tube). The investigators thought increasing resistant starch and reducing sugar would reduce the glucose and insulin responses, and that adding protein would reduce glucose and increase insulin. The investigators also thought the glucose and insulin responses in people would be related to the rate of digestion of the food bars in-vitro.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body mass index 20.0 to 34.9 kg/m²

• Fasting serum glucose <7.0mmol/L

• Non-smoker

Exclusion Criteria:

• Known to have diabetes

• Use of medications or presence of a medical condition considered by the principal investigator to increase risk to the participant or affect the results

• Known food allergy of any kind

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Control 1
67g of control bar
• Control 2
86g of control bar
• 15/0
66g of experimental bar 15/0
• 15/0LS
84g of experimental bar 15/0LS
• 15/5
75g of experimental bar 15/5
• 10/5
72g of experimental bar 10/5
• 10/10
80g of experimental bar 10/10

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc.	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Glycemic Index Laboratories, Inc	PepsiCo Global R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under the blood glucose response curve		For 3 hours after consuming each test meal	No
Secondary	Incremental area under the serum insulin response curve		For 3 hours after consuming each test meal	No
Secondary	Incremental area under the blood glucose response curve		For 2 hours after consuming each test meal	No
Secondary	Incremental area under the serum insulin response curve		For 2 hours after consuming each test meal	No
Secondary	Insulin:Glucose area under the curve ratio	Outcome 2 (incremental area under the insulin response curve for 3 hours) divided by Outcome 1 (incremental area under the glucose response curve for 3 hours)	For 3 hours after consuming each test meal	No
Secondary	Insulin:Glucose area under the curve ratio	Outcome 4 (incremental area under the insulin response curve for 2 hours) divided by Outcome 3 (incremental area under the glucose response curve for 2 hours)	For 2 hours after consuming each test meal	No
Secondary	Insulinogenic index	I30 divided by G30; where I30 is the serum insulin increment at 30 minutes and G30 is the blood glucose increment at 30 minutes; and where "increment" is defined as the concentration at 30 minutes minus the fasting concentration.	30 minutes after consuming each test meal	No