PEP-1324: Glycemic Response Testing

Glycemic Response Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02037854
• Other study ID #: PEP-1324
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2014
• Last updated: October 29, 2014
• Start date: January 2014

Study information

• Verified date: October 2014
• Source: PepsiCo Global R&D
• Contact: Janice Campbell
• Email: JCampbell[@]gilabs.com
• Is FDA regulated: No
• Health authority: Canada: WIRB
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject is 18-75 years of age

• Subject is male or non-pregnant females, 18-75 years of age, inclusive

• Subject has a body mass index (BMI) = 20.0 and < 35 kg/m² at screening (visit 1).

• Subject has to be non-smoker.

• Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.

• Subject is willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.

• Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).

• Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.

• Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.

• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glycemic Response

Intervention

Other:
• Nutrient formulation

Locations

Country	Name	City	State
Canada	GI Labs	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under the blood glucose response cruve		0-2 hours	No
Secondary	peak blood glucose		0-2 hours	No
Secondary	peak insulin		0-2 hours	No