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Clinical Trials/NCT02537587
NCT02537587CompletedNot Applicable

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

Glycemic Index Laboratories, Inc1 site in 1 country12 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Incremental area under the blood glucose response curve

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control 1

Active Comparator

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

Intervention: Control 1 (Other)

Control 2

Active Comparator

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

Intervention: Control 2 (Other)

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

Intervention: 15/0 (Other)

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

Intervention: 15/0LS (Other)

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

Intervention: 15/5 (Other)

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

Intervention: 10/5 (Other)

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

Intervention: 10/10 (Other)

Outcomes

Primary Outcomes

Incremental area under the blood glucose response curve

Time Frame: For 3 hours after consuming each test meal

Secondary Outcomes

  • 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)
  • 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)
  • Incremental area under the serum insulin response curve(For 3 hours after consuming each test meal)
  • Insulin:Glucose area under the curve ratio(For 3 hours after consuming each test meal)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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