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

NCT02537587 | Completed

• 2 other identifiers: GIL-1342PEP-1324
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Blood glucose; Blood insulin; Humans; Postprandial; Carbohydrate; Protein; Resistant starch; Sugar

Outcome Measures

Primary Outcomes (1)

• Incremental area under the blood glucose response curve

  For 3 hours after consuming each test meal

Secondary Outcomes (6)

• Incremental area under the serum insulin response curve

  For 3 hours after consuming each test meal

• 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 2 hours after consuming each test meal

• Insulin:Glucose area under the curve ratio

  For 3 hours after consuming each test meal

• Insulin:Glucose area under the curve ratio

  For 2 hours after consuming each test meal

Study Arms (7)

Control 1

ACTIVE COMPARATOR

67g of Control energy bar containing 4g protein, 15g fat, 42g carbohydrate, 2g fiber, and 24g sugar.

Other: Control 1

Control 2

ACTIVE COMPARATOR

86g of Control energy bar containing 5g protein, 20g fat, 55g carbohydrate, 3g fiber and 30g sugar

Other: Control 2

15/0

EXPERIMENTAL

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

15/0-LS

EXPERIMENTAL

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

15/5

EXPERIMENTAL

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

10/5

EXPERIMENTAL

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

10/10

EXPERIMENTAL

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

Interventions

Control 1 OTHER

67g of control bar

Control 1

Control 2 OTHER

86g of control bar

Control 2

15/0 OTHER

66g of experimental bar 15/0

15/0

15/0LS OTHER

84g of experimental bar 15/0LS

15/0-LS

15/5 OTHER

75g of experimental bar 15/5

15/5

10/5 OTHER

72g of experimental bar 10/5

10/5

10/10 OTHER

80g of experimental bar 10/10

10/10

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index 20.0 to 34.9 kg/m²
• Fasting serum glucose \<7.0mmol/L
• Non-smoker

You may not qualify if:

• 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

Sponsors & Collaborators

• Glycemic Index Laboratories, Inc: lead
• PepsiCo Global R&D: collaborator

Study Sites (1)

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27581470 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas MS Wolever, MD, PhD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

CA (1)