Status:
COMPLETED
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
Lead Sponsor:
TNO
Collaborating Sponsors:
Yakult Honsha Co., LTD
Conditions:
Health
Blood Pressure
Eligibility:
All Genders
40-70 years
Phase:
NA
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 in...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Healthy as assessed by the: Health and Lifestyle Questionnaire, results of the pre study laboratory tests in blood
- Males/Females aged 40-70 years (boundaries included) at Day 01 of the study
- Body Mass Index (BMI) 25-35 (boundaries included) kg/m2
- Liver enzymes above reference values GGT ≥ 45 IU/L (for males) and ≥ 35 IU/L (for females), and/or ASAT ≥ 45 IU/L (for males and females), and/or ALAT ≥ 50 IU/L (for males) and ≥ 40 IU/L (for females)
- Blood pressure (automated measurements at site): systolic blood pressure 130-159 mm Hg (boundaries included) and/or diastolic blood pressure 85-99 mm Hg (boundaries included)
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Willing to give up blood/plasma donation during the study
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome
- Any concomitant medication, with the exception of occasional use of a paracetamol tablet, that may influence the outcome of the study (to be judged by the medical investigator)
- Food allergy/intolerance
- Alcohol consumption \> 28 units/week for males and \> 21 units/week for females
- Smoking \> 10 cigarettes per day
- Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre study screening
- Reported slimming or medically prescribed diet
- Participation in night shift work
- Pregnant or lactating or wishing to become pregnant in the period of the study
- Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00962195
Start Date
June 1 2009
End Date
December 1 2009
Last Update
April 14 2010
Active Locations (1)
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1
TNO Quality of Life
Zeist, Utrecht, Netherlands