HyperlipidemiaNCT04672278
Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients
A study of Hyperlipidemia and Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia, Hypertension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2019to 30 Oct 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
- Mean plasma triglyceride >= 4.5 mmol/l.
- Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
- Be able to give written informed consent prior to study start and comply with study requirements.
Who cannot join
- • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
- Mean plasma triglyceride < 4.5 mmol/l.
- Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
- Be able to give written informed consent prior to study start and comply with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Safety, Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients With Mild to Moderate Hyperlipidemia
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.
- Conditions
- Hyperlipidemia, Hypertension
- Being tested
- Shanzha Fruit drink or placebo drink
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shanzha Fruit drink or placebo drinkDietary supplement
Also called placebo
The dosage of Shanzha fruit drink or the placebo is 3 cans per day
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Dietary Supplement: Shanzha Fruit drink or placebo drink |
| Group B | Experimental | Not described Receives: Dietary Supplement: Shanzha Fruit drink or placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia
The lipid profile including total cholesterol, HDL cholesterol, LDL-cholesterol and triglycerides will be measured at the start and the end of the study and changes from the baseline to the end of the treatment will be evaluated.
Measured: 5 months.
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
Alanine transaminase (ALT) levels as the main liver function test will be measured at the start and the end of the study.
Measured: 5 months.
Secondary outcomes (2)
To evaluate the hypotensive effect of Shanzha Fruit Drink
The changes in the systolic and diastolic blood pressure from the baseline to the end of the treatment will be evaluated.
Measured: 5 months.
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by recording any adverse events reported by the study subjects or noted by the investigator.
Any adverse events reported by the study subjects or noted by the investigator will be recorded at all the study visits after the initial study visit.
Measured: 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Jan 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Tomlinson, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672278
- Sponsor's protocol ID
- BS/CR/PC/01
- Status last verified
- Apr 2021
- First submitted
- 14 Dec 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Safety, Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients With Mild to Moderate Hyperlipidemia
- ClinicalTrials.gov ID
- NCT04672278
- Acronym / sponsor ID
- BS/CR/PC/01
- Conditions
- Hyperlipidemia, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- 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.
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Shanzha Fruit drink or placebo drink |
| Group B | Experimental | Dietary Supplement: Shanzha Fruit drink or placebo drink |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
Key exclusion criteria (4 listed)
- • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
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 |
|---|---|---|
| Shanzha Fruit drink or placebo drinkAlso: placeboThe dosage of Shanzha fruit drink or the placebo is 3 cans per day | Dietary supplement | Group A, Group B |
Primary outcome
To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia
Time frame: 5 months.
The lipid profile including total cholesterol, HDL cholesterol, LDL-cholesterol and triglycerides will be measured at the start and the end of the study and changes from the baseline to the end of the treatment will be evaluated.
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
Time frame: 5 months.
Alanine transaminase (ALT) levels as the main liver function test will be measured at the start and the end of the study.
2 secondary outcomes
To evaluate the hypotensive effect of Shanzha Fruit Drink
Time frame: 5 months.
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by recording any adverse events reported by the study subjects or noted by the investigator.
Time frame: 5 months.
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 23 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hyperlipidemia and Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 4 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 23 Apr 2021. 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 Hong Kong. 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. 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?
To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia (time frame: 5 months.). The study lists 2 primary outcomes in all. 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 23 Apr 2021.