NCT02037854

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

January 13, 2014

Last Update Submit

October 29, 2014

Conditions

Glycemic Response

Outcome Measures

Primary Outcomes (1)

  • Incremental area under the blood glucose response cruve

    0-2 hours

Secondary Outcomes (2)

  • peak blood glucose

    0-2 hours

  • peak insulin

    0-2 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A nutrient formulation without the active ingredient

Other: Nutrient formulation

Nutrient formulation

EXPERIMENTAL

Nutrient formulations with variable amounts of active ingredients.

Other: Nutrient formulation

Interventions

Nutrient formulationOTHER
Nutrient formulationPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GI Labs

Toronto, Ontario, M5C 2N8, Canada

RECRUITING

Central Study Contacts

Janice Campbell

CONTACT

JCampbell@gilabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

CA(1)