Postprandial Glycemic Response to Polyphenol-fortified Snack Bars
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Natick, Massachusetts, United States, 01760
- USARIEM
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Soldiers who are stationed with USARIEM, NSRDEC or the U.S. Army Natick Soldier Center pool of military participants, or any civilians will be invited to participate in this study.
Exclusion Criteria:
- Potential participants will be excluded from participation if they: are under the age of 18 or over the age of 39 (i.e. insulin sensitivity declines with age, hence the upper age limit of 39 years); have a pre-existing liver disease, history of alcoholism or typically consume more than 4 alcoholic beverages daily or 6 on one occasion more than once a month within the past 6 months; have impaired glucose metabolism due to diabetes, pre-diabetes, galactosemia, hereditary fructose intolerance or glycogen storage disease; have thyroid disease; have a bleeding disorder (e.g., von Willebrand Disease, hemophilia) or are being treated with medication that will impair blood clotting; have a history of GI-related conditions that may impact glucose absorption (e.g., Crohn's disease, ulcerative colitis, Celiac's disease or gluten sensitivity, bariatric surgery or gastroparesis); are taking any medications affecting carbohydrate metabolism (e.g., insulin or oral diabetes medications); and/or, have an allergy or aversion to any of the test foods.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Food bar without fruit
snack bar without fruit
|
|
|
Experimental: Food bar with cranberry extract (0.5%)
Snack bar with cranberry extract (0.5% total weight)
|
|
|
Experimental: Food bar with cranberry extract (1.0%)
Snack bar with cranberry extract (1.0% total weight)
|
|
|
Experimental: Food bar w/ dried black raspberry (10%)
Snack bar with freeze-dried black raspberry(10% total weight)
|
|
|
Experimental: Food bar w/ dried black raspberry (20%)
Snack bar with freeze-dried black raspberry (20% total weight)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
blood glucose concentrations
Time Frame: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
|
fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
gut hormones
Time Frame: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
|
fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
|
|
blood concentration of phenolic acids
Time Frame: fasting, post-prandial 60 minutes, 120 minutes and 180 minutes
|
fasting, post-prandial 60 minutes, 120 minutes and 180 minutes
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Tracey J Smith, PhD, United States Army Research Institute of Environmental Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 15-28-HC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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