HealthNCT00962195
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
A study testing purple sweet potato (PSP)-juice in people with Health and Blood Pressure, run by TNO at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Blood Pressure, Liver Function
- What is being tested?
- purple sweet potato (PSP)-juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Health, Blood Pressure, Liver Function, Insulin Resistance
- Being tested
- purple sweet potato (PSP)-juice
- Keywords
- health, blood pressure, liver enzymes, insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
purple sweet potato (PSP)-juiceDietary supplement
Daily oral intake of 3x 125 ml of PSP-juice or control juice
| Study group | Role | What they receive |
|---|---|---|
| purple sweet potato juice | Experimental | Daily oral intake of 3x 125 ml of PSP-juice for a period of 8 weeks Receives: Dietary Supplement: purple sweet potato (PSP)-juice |
| Control juice | Placebo comparator | Daily oral intake of 3x 125 ml of control juice for a period of 8 weeks Receives: Dietary Supplement: purple sweet potato (PSP)-juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver enzymes
Measured: every 2 weeks during 8-weeks intervention
Secondary outcomes (2)
blood pressure
Measured: every 2 weeks during 8-weeks intervention
insulin resistance
Measured: every 2 weeks during 8-weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Investigators
- Esther Boelsma, PhD, Principal investigator, TNOIneke Klopping-Ketelaars, PhD, Study director, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962195
- Sponsor's protocol ID
- P8604
- Status last verified
- Apr 2010
- First submitted
- 18 Aug 2009
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
- ClinicalTrials.gov ID
- NCT00962195
- Acronym / sponsor ID
- P8604
- Conditions
- Health, Blood Pressure, Liver Function, Insulin Resistance
- Keywords
- health, blood pressure, liver enzymes, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| purple sweet potato juice | Experimental | Dietary Supplement: purple sweet potato (PSP)-juiceDaily oral intake of 3x 125 ml of PSP-juice for a period of 8 weeks |
| Control juice | Placebo comparator | Dietary Supplement: purple sweet potato (PSP)-juiceDaily oral intake of 3x 125 ml of control juice for a period of 8 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| purple sweet potato (PSP)-juiceDaily oral intake of 3x 125 ml of PSP-juice or control juice | Dietary supplement | Control juice, purple sweet potato juice |
Primary outcome
liver enzymes
Time frame: every 2 weeks during 8-weeks intervention
2 secondary outcomes
blood pressure
Time frame: every 2 weeks during 8-weeks intervention
insulin resistance
Time frame: every 2 weeks during 8-weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Boelsma, PhD principal investigator
TNO
Ineke Klopping-Ketelaars, PhD study director
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing purple sweet potato (PSP)-juice in people with Health and Blood Pressure, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver enzymes (time frame: every 2 weeks during 8-weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2010.