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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Control 1; Other: Control 2; Other: 15/0; Other: 15/0LS; Other: 15/5; Other: 10/5; Other: 10/10

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic Index Laboratories, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control 1; 67g of Control energy bar containing 4g protein, 15g fat, 42g carbohydrate, 2g fiber, and 24g sugar.	Other: Control 1; 67g of control bar
Active Comparator: Control 2; 86g of Control energy bar containing 5g protein, 20g fat, 55g carbohydrate, 3g fiber and 30g sugar	Other: Control 2; 86g of control bar
Experimental: 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	Other: 15/0; 66g of experimental bar 15/0
Experimental: 15/0-LS; 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	Other: 15/0LS; 84g of experimental bar 15/0LS
Experimental: 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	Other: 15/5; 75g of experimental bar 15/5
Experimental: 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	Other: 10/5; 72g of experimental bar 10/5
Experimental: 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	Other: 10/10; 80g of experimental bar 10/10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incremental area under the blood glucose response curve	For 3 hours after consuming each test meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental area under the blood glucose response curve		For 2 hours after consuming each test meal
Incremental area under the serum insulin response curve		For 3 hours after consuming each test meal
Incremental area under the serum insulin response curve		For 2 hours after consuming each test meal
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
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
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

Collaborators and Investigators

• Sponsor: Glycemic Index Laboratories, Inc
• Collaborators: PepsiCo Global R&D

Publications and helpful links

General Publications

• Wolever TM, van Klinken BJ, Bordenave N, Kaczmarczyk M, Jenkins AL, Chu Y, Harkness L. Reformulating cereal bars: high resistant starch reduces in vitro digestibility but not in vivo glucose or insulin response; whey protein reduces glucose but disproportionately increases insulin. Am J Clin Nutr. 2016 Oct;104(4):995-1003. doi: 10.3945/ajcn.116.132431. Epub 2016 Aug 31.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Humans; Protein; Carbohydrate; Postprandial; Blood glucose; Sugar; Resistant starch; Blood insulin
• Other Study ID Numbers: GIL-1342; PEP-1324 (PepsiCo)