- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927015
Glucose Response From Antioxidant Rich Potato Chips
October 5, 2016 updated by: Richard Mattes, Purdue University
Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preclinical data obtained using an Caco-2 intestinal cell model and enzyme assays suggest phenolic-rich potato extracts decrease intestinal glucose transport.
The aim is to determine if these effects extend to the the an in vivo situation.
Specifically, the glycemic response following consumption of phenolic rich pigmented potatoes compared to white potatoes with lower phenolic content will be measured.
Gastric emptying will also be measured to show the effects are in fact due to rate of carbohydrate digestion and intestinal glucose transport and not gastric emptying rate.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 18-25 non-smoker
Exclusion Criteria:
- BMI outside 18-25 smoker previous gastrointestinal disease or other disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Purple Majesty potato chips
|
Purple Majesty potato chips
|
|
EXPERIMENTAL: Mountain Rose potato chips
|
Mountain Rose potato chips
|
|
EXPERIMENTAL: White potato chips
|
White potato chips
|
|
EXPERIMENTAL: Crackers
|
Crackers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Glucose
Time Frame: up to 2 hours
|
blood taken at 10, 20, 30, 60, and 120 minutes by finger prick
|
up to 2 hours
|
|
Gastric emptying
Time Frame: up to 4 hours
|
Breath Hydrogen concentrations will be measured every 15 minutes for 4 hours
|
up to 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (ACTUAL)
February 1, 2016
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
October 5, 2016
First Posted (ESTIMATE)
October 6, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
October 6, 2016
Last Update Submitted That Met QC Criteria
October 5, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 055-043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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