Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00962195
Status:
COMPLETED
Last Update Posted:
2010-04-14
First Post:
2009-08-18
Brief Title:
The Effect of Purple Sweet Potato PSP-Juice on Liver Enzymes and Blood Pressure
Sponsor:
TNO
Organization:
TNO
Study Overview
Official Title:
The Effect of Purple Sweet Potato PSP-Juice on Liver Enzymes and Blood Pressure
Status:
COMPLETED
Status Verified Date:
2010-04
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:
Purple Sweet Potato juice PSP-juice is a juice based on purple-fleshed sweet potato concentrate containing a high level of anthocyanins Purple-fleshed sweet potatoes have attracted attention to industry and scientists due to multiple physiological functions such as radical-scavenging ACE-inhibitory and α-glucosidase inhibitory activities in vitro and also hepato-protective antihypertensive and antihyperglycemic effects in vivo Previous studies in Japanese subjects showed potential beneficial effects of PSP beverages on liver function and blood pressure in volunteers with impaired hepatic function andor hypertension
The main objective of this study is to examine the effect of PSP-juice on liver enzymes and blood pressure The secondary objective is to examine the effects of PSP-juice juice on insulin resistance
The main objective of this study is to examine the effect of PSP-juice on liver enzymes and blood pressure The secondary objective is to examine the effects of PSP-juice juice on insulin resistance
Detailed Description:
Study design The study is designed as a randomized parallel placebo-controlled double-blind study
Study population 40 healthy adult female andor male subjects 40-70 yr old with a BMI 25-35 kgm2 mildly elevated serum liver enzymes and high normal blood pressure or mild hypertension
Intervention Daily oral intake of 3x 125 ml of PSP-juice or control juice for a period of 8 weeks
Main study parametersendpoints Liver enzymes GGT ALAT ASAT blood pressure glucose insulin haematology and serum clinical chemical profile
Study population 40 healthy adult female andor male subjects 40-70 yr old with a BMI 25-35 kgm2 mildly elevated serum liver enzymes and high normal blood pressure or mild hypertension
Intervention Daily oral intake of 3x 125 ml of PSP-juice or control juice for a period of 8 weeks
Main study parametersendpoints Liver enzymes GGT ALAT ASAT blood pressure glucose insulin haematology and serum clinical chemical profile
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