NCT02927015

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

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, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

October 4, 2016

Last Update Submit

October 5, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose

    blood taken at 10, 20, 30, 60, and 120 minutes by finger prick

    up to 2 hours

  • Gastric emptying

    Breath Hydrogen concentrations will be measured every 15 minutes for 4 hours

    up to 4 hours

Study Arms (4)

Purple Majesty potato chips

EXPERIMENTAL

Purple Majesty potato chips

Other: Purple Majesty potato chips

Mountain Rose potato chips

EXPERIMENTAL

Mountain Rose potato chips

Other: Mountain Rose potato chips

White potato chips

EXPERIMENTAL

White potato chips

Other: White potato chips

Crackers

EXPERIMENTAL

Crackers

Other: Crackers

Interventions

Purple Majesty potato chips

Purple Majesty potato chips

Mountain Rose potato chips

Mountain Rose potato chips

White potato chips

White potato chips

Crackers

Crackers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-25 non-smoker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Nutrition Sciences

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 6, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share