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

NCT ID: NCT02537587

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control 1

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

Group Type ACTIVE_COMPARATOR

Control 1

Intervention Type OTHER

67g of control bar

Control 2

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

Group Type ACTIVE_COMPARATOR

Control 2

Intervention Type OTHER

86g of control bar

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

Group Type EXPERIMENTAL

15/0

Intervention Type OTHER

66g of experimental bar 15/0

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

Group Type EXPERIMENTAL

15/0LS

Intervention Type OTHER

84g of experimental bar 15/0LS

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

Group Type EXPERIMENTAL

15/5

Intervention Type OTHER

75g of experimental bar 15/5

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

Group Type EXPERIMENTAL

10/5

Intervention Type OTHER

72g of experimental bar 10/5

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

Group Type EXPERIMENTAL

10/10

Intervention Type OTHER

80g of experimental bar 10/10

Interventions

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Control 1

67g of control bar

Intervention Type OTHER

Control 2

86g of control bar

Intervention Type OTHER

15/0

66g of experimental bar 15/0

Intervention Type OTHER

15/0LS

84g of experimental bar 15/0LS

Intervention Type OTHER

15/5

75g of experimental bar 15/5

Intervention Type OTHER

10/5

72g of experimental bar 10/5

Intervention Type OTHER

10/10

80g of experimental bar 10/10

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role collaborator

Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Locations

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Glycemic Index Laboratories, Inc.

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27581470 (View on PubMed)

Other Identifiers

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PEP-1324

Identifier Type: OTHER

Identifier Source: secondary_id

GIL-1342

Identifier Type: -

Identifier Source: org_study_id

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