Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01720511
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2012-10-30
Brief Title:
Pilot Study of the Effect of Purple Rice on Glucose Tolerance Serum Lipids and Inflammation
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Pilot Study of the Effect of Purple Rice on Glucose Tolerance Serum Lipids and Inflammation
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and insulin The purple color is due like red wine grapes mainly to the anthocyanins The safety and tolerability of purple rice is similar to white or brown rice but contains the purple elements common to other foods like grapes
Detailed Description:
This is a study that will have 1 screening visit and 9 study visits Subjects will come to the screening visit for blood chemistry health questionnaire and speak to the coordinator Each subject passing inclusionexclusion will go on to eat purple rice for 4 weeks and brown rice for 4 weeks The 4-week feeding periods will be balanced and assigned randomly The subjects will report to the metabolic kitchen to pick up their supply of 14 frozen rice dishes each week in a container and return the empty containers as a measure of compliance At the end of each 4-week feeding period subjects will come to the inpatient unit fasting from 9pm the prior night except for water Subjects will have an intravenous line placed and fasting blood will be drawn for chemistry Subjects will then be given glucose to drink and blood will be drawn from then IV line for glucose and insulin at time listed in the consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None