Skip to main content
OpenTrials
Completed

NCT Number: NCT02537587

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control 1

Other

67g of control bar

Control 2

Other

86g of control bar

15/0

Other

66g of experimental bar 15/0

15/0LS

Other

84g of experimental bar 15/0LS

15/5

Other

75g of experimental bar 15/5

10/5

Other

72g of experimental bar 10/5

10/10

Other

80g of experimental bar 10/10

Primary outcomes

  1. Incremental area under the blood glucose response curve

    Time frame: For 3 hours after consuming each test meal

Secondary outcomes

  1. Incremental area under the serum insulin response curve

    Time frame: For 3 hours after consuming each test meal

  2. Incremental area under the blood glucose response curve

    Time frame: For 2 hours after consuming each test meal

  3. Incremental area under the serum insulin response curve

    Time frame: For 2 hours after consuming each test meal

  4. Insulin:Glucose area under the curve ratio

    Time frame: For 3 hours after consuming each test meal

    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)

  5. Insulin:Glucose area under the curve ratio

    Time frame: For 2 hours after consuming each test meal

    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)

  6. Insulinogenic index

    Time frame: 30 minutes after consuming each test meal

    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.

Sponsors and collaborators

Lead sponsor

Glycemic Index Laboratories, Inc

Industry

Collaborators

  • PepsiCo Global R&D

Registry information

Acronym: Solstice

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2015
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.