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

Glycemic Index Laboratories

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: 10/5; Other: 10/10; Other: 15/5; Other: Control 2; Other: 15/0; Other: 15/0LS; Other: Control 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537587

GIL-1342

PEP-1324

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 7 patient groups

Control 1

Active Comparator group

Description:

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

Treatment:

Other: Control 1

Control 2

Active Comparator group

Description:

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

Treatment:

Other: Control 2

15/0

Experimental group

Description:

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

Treatment:

Other: 15/0

15/0-LS

Experimental group

Description:

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

Treatment:

Other: 15/0LS

15/5

Experimental group

Description:

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

Treatment:

Other: 15/5

10/5

Experimental group

Description:

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

Treatment:

Other: 10/5

10/10

Experimental group

Description:

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

Treatment:

Other: 10/10