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The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure

Primary Purpose

Health, Blood Pressure, Liver Function

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
purple sweet potato (PSP)-juice
Sponsored by
TNO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Health focused on measuring health, blood pressure, liver enzymes, insulin resistance

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • TNO Quality of Life

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

purple sweet potato juice

Control juice

Arm Description

Daily oral intake of 3x 125 ml of PSP-juice for a period of 8 weeks

Daily oral intake of 3x 125 ml of control juice for a period of 8 weeks

Outcomes

Primary Outcome Measures

liver enzymes

Secondary Outcome Measures

blood pressure
insulin resistance

Full Information

First Posted
August 18, 2009
Last Updated
April 13, 2010
Sponsor
TNO
Collaborators
Yakult Honsha Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT00962195
Brief Title
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
Official Title
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
TNO
Collaborators
Yakult Honsha Co., LTD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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/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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health, Blood Pressure, Liver Function, Insulin Resistance
Keywords
health, blood pressure, liver enzymes, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
purple sweet potato juice
Arm Type
Experimental
Arm Description
Daily oral intake of 3x 125 ml of PSP-juice for a period of 8 weeks
Arm Title
Control juice
Arm Type
Placebo Comparator
Arm Description
Daily oral intake of 3x 125 ml of control juice for a period of 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
purple sweet potato (PSP)-juice
Intervention Description
Daily oral intake of 3x 125 ml of PSP-juice or control juice
Primary Outcome Measure Information:
Title
liver enzymes
Time Frame
every 2 weeks during 8-weeks intervention
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
every 2 weeks during 8-weeks intervention
Title
insulin resistance
Time Frame
every 2 weeks during 8-weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Boelsma, PhD
Organizational Affiliation
TNO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ineke Klopping-Ketelaars, PhD
Organizational Affiliation
TNO
Official's Role
Study Director
Facility Information:
Facility Name
TNO Quality of Life
City
Zeist
State/Province
Utrecht
Country
Netherlands

12. IPD Sharing Statement

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The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure

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