Clinical trial NCT02537587: Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact
Official title: Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Blood glucose
Blood insulin
Humans
Postprandial
Carbohydrate
Protein
Resistant starch
Sugar
Lead sponsor: Glycemic Index Laboratories, Inc
Sponsor class: INDUSTRY
Collaborators: name: PepsiCo Global R&D
First posted: 2015-09-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incremental area under the blood glucose response curve
timeFrame: For 3 hours after consuming each test meal
Secondary outcomes:
measure: Incremental area under the serum insulin response curve
timeFrame: For 3 hours after consuming each test meal
measure: Incremental area under the blood glucose response curve
timeFrame: For 2 hours after consuming each test meal
measure: Incremental area under the serum insulin response curve
timeFrame: For 2 hours after consuming each test meal
measure: Insulin:Glucose area under the curve ratio
timeFrame: For 3 hours after consuming each test meal
measure: Insulin:Glucose area under the curve ratio
timeFrame: For 2 hours after consuming each test meal
measure: Insulinogenic index
timeFrame: 30 minutes after consuming each test meal
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc.
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.