Insulin Resistance Clinical Trial
Official title:
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
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 and/or
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.
Study design: The study is designed as a randomized, parallel, placebo-controlled,
double-blind study.
Study population: 40 healthy adult female and/or male subjects, 40-70 yr old with a BMI
25-35 kg/m2, 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 parameters/endpoints: Liver enzymes (GGT, ALAT, ASAT), blood pressure, glucose,
insulin, haematology and serum clinical chemical profile
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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