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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Control 1
* Other: Control 2
* Other: 15/0
* Other: 15/0LS
* Other: 15/5
* Other: 10/5
* Other: 10/10


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose, Blood insulin, Humans, Postprandial, Carbohydrate, Protein, Resistant starch, Sugar