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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02927015
Other study ID # 055-043
Secondary ID
Status Completed
Phase N/A
First received October 4, 2016
Last updated October 5, 2016
Start date January 2016
Est. completion date June 2016

Study information

Verified date October 2016
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date June 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- BMI 18-25 non-smoker

Exclusion Criteria:

- BMI outside 18-25 smoker previous gastrointestinal disease or other disease

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Purple Majesty potato chips
Purple Majesty potato chips
Mountain Rose potato chips
Mountain Rose potato chips
White potato chips
White potato chips
Crackers
Crackers

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Purdue University PepsiCo Global R&D

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Glucose blood taken at 10, 20, 30, 60, and 120 minutes by finger prick up to 2 hours No
Primary Gastric emptying Breath Hydrogen concentrations will be measured every 15 minutes for 4 hours up to 4 hours No
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