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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: 15/0; Other: Control 1; Other: Control 2; Other: 10/10; Other: 15/0LS; Other: 15/5; Other: 10/5

• Registration Number: NCT02537587
• Lead Sponsor: Glycemic Index Laboratories, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-08
• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study First Posted: 2015-09-01
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
15/0	15/0	Experimental bar with 15% added resistant starch and 0% added protein; 66g portion containing 3g protein, 7g fat, 50g carbohydrate, 10g fiber and 16g sugar
Control 1	Control 1	67g of Control energy bar containing 4g protein, 15g fat, 42g carbohydrate, 2g fiber, and 24g sugar.
Control 2	Control 2	86g of Control energy bar containing 5g protein, 20g fat, 55g carbohydrate, 3g fiber and 30g sugar
10/10	10/10	Experimental bar with 10% added resistant starch and 10% added protein; 80g portion containing 17g protein, 7g fat, 49g carbohydrate, 9g fiber and 18g sugar
15/0-LS	15/0LS	Experimental bar with 15% added resistant starch and 0% added protein with reduced sugar; 84g portion containing 4g protein, 8g fat, 55g carbohydrate, 15g fiber and 15g sugar
15/5	15/5	Experimental bar with 15% added resistant starch and 5% added protein; 75g portion containing 9g protein, 7g fat, 52g carbohydrate, 12g fiber and 17g sugar
10/5	10/5	Experimental bar with 10% added resistant starch and 5% added protein; 72g portion containing 10g protein, 8g fat, 49g carbohydrate, 9g fiber and 19g sugar

Primary Outcome Measures

Name	Time	Method
Incremental area under the blood glucose response curve	For 3 hours after consuming each test meal

Secondary Outcome Measures

Name	Time	Method
Incremental area under the serum insulin response curve	For 2 hours after consuming each test meal
Insulinogenic index	30 minutes after consuming each test meal	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.
Incremental area under the blood glucose response curve	For 2 hours after consuming each test meal
Insulin:Glucose area under the curve ratio	For 2 hours after consuming each test meal	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)

Trial Locations

Locations (1)

Glycemic Index Laboratories, Inc.; 🇨🇦 Toronto, Ontario, Canada