DyslipidemiaPhase 2COME-PASSNCT02541201
The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (COME-PASS)
A Phase 2 study testing Plant sterols-enriched low-fat milk and Low-fat milk in people with Dyslipidemia, run by The University of Hong Kong.
Trial summary
This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Plant sterols-enriched low-fat milk and Low-fat milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Southern Chinese male or female ≥ 18years.
- In good general health as evidenced by medical history
- Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and discloser of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form
Who cannot join
- Subject with familial hypercholesterolemia
- Ingestion of drugs known to interfere with lipid profiles, such as hormone replacement treatment, diuretics, beta-blockers, statin or other hypochoelsterolemic drug treatment
- Smoking > 10 cigarettes/day
- Subject with heavy alcohol intake (Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day)
- Having milk intolerance or dislike
- Having major diseases such as diabetes (type I and type II), renal or liver diseases
Show all 12Show fewer
- Subject presenting known allergy or hypersensitivity to milk proteins, soy and peanut
- Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product)
- Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
- Pregnancy or lactation
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
About this study
Official title: The Effect of the Consumption of Low-Fat Milk Enriched With Plant Sterols on Serum Low-Density Lipoprotein Cholesterol in Healthy Southern Chinese (COME-PASS)
This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of the participants will consume of 1.5g of plant sterols daily as provided by two servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half will consume placebo low-fat milk.
Read the detailed description
Plant sterols are the naturally occurring functional equivalent of mammalian cholesterol. Plant sterols differ structurally from cholesterol by a methyl or ethyl group in their side chains and are not synthesized by the human body. These structural differences render them minimally absorbable in the intestine. It has been consistently reported that dietary incorporation of plant sterols(1.5-2 g/day) reduces serum low-density lipoprotein cholesterol (LDL-C) levels with minimal adverse events. The hypochoelsterolemic effects of plant sterols is explained by an inhibition of cholesterol absorption, which is ascribed to a competition with intestinal cholesterol for incorporation into mixed micelles, although other possible mechanistic explanation have been proposed.
- Conditions
- Dyslipidemia
- Being tested
- Plant sterols-enriched low-fat milk, Low-fat milk
- Keywords
- Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterols-enriched low-fat milkDietary supplement
The study product is a dried partly skimmed milk powder with no more than 12% milk fat (11.4g total fat/100g product) containing unesterified, unhydrogenated plant sterols.
Low-fat milkDietary supplement
The placebo product is a dried partly skimmed milk powder.
| Study group | Role | What they receive |
|---|---|---|
| Plant sterols-enriched low-fat milk | Experimental | Daily consumption of 1.5g of plant sterols as provided by two servings of 273 ml of plant sterols-enriched low-fat milk for consecutive 3 weeks, each serving taken right before breakfast and lunch. Receives: Dietary Supplement: Plant sterols-enriched low-fat milk |
| Low-fat milk | Placebo comparator | Daily consumption of two servings of 273 ml of low-fat milk (without plant sterols) for consecutive 3 weeks, each serving taken right before breakfast and lunch. Receives: Dietary Supplement: Low-fat milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of serum low-density lipoprotein cholesterol (LDL-C)
Measured: From baseline to week 3
Secondary outcomes (6)
Change of serum LDL-C
Measured: From baseline to week 3
Change of high-density lipoprotein cholesterol (HDL-C)
Measured: From baseline to week 3
Change of total cholesterol
Measured: From baseline to week 3
Change of triglycerides (TAG)
Measured: From baseline to week 3
Change of serum creatinine
Measured: From baseline to week 3
Changes of fasting blood glucose
Measured: From baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bernard Cheung, The University of Hong Kong
- Investigators
- Cheung Bernard Man Yung, Principal investigator, Li Ka Shing Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541201
- Sponsor's protocol ID
- CTC1430
- Acronym
- COME-PASS
- Status last verified
- Oct 2015
- First submitted
- 26 Aug 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheung CL, Ho DK, Sing CW, Tsoi MF, Cheng VK, Lee GK, Ho YN, Cheung BM. Randomized controlled trial of the effect of phytosterols-enriched low-fat milk on lipid profile in Chinese. Sci Rep. 2017 Jan 24;7:41084. doi: 10.1038/srep41084.
PubMed 28117400
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Consumption of Low-Fat Milk Enriched With Plant Sterols on Serum Low-Density Lipoprotein Cholesterol in Healthy Southern Chinese (COME-PASS)
- ClinicalTrials.gov ID
- NCT02541201
- Acronym / sponsor ID
- COME-PASS / CTC1430
- Conditions
- Dyslipidemia
- Keywords
- Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Sep 2015 (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.
This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of the participants will consume of 1.5g of plant sterols daily as provided by two servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half will consume placebo low-fat milk.
Detailed description
Plant sterols are the naturally occurring functional equivalent of mammalian cholesterol. Plant sterols differ structurally from cholesterol by a methyl or ethyl group in their side chains and are not synthesized by the human body. These structural differences render them minimally absorbable in the intestine. It has been consistently reported that dietary incorporation of plant sterols(1.5-2 g/day) reduces serum low-density lipoprotein cholesterol (LDL-C) levels with minimal adverse events. The hypochoelsterolemic effects of plant sterols is explained by an inhibition of cholesterol absorption, which is ascribed to a competition with intestinal cholesterol for incorporation into mixed micelles, although other possible mechanistic explanation have been proposed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant sterols-enriched low-fat milk | Experimental | Dietary Supplement: Plant sterols-enriched low-fat milkDaily consumption of 1.5g of plant sterols as provided by two servings of 273 ml of plant sterols-enriched low-fat milk for consecutive 3 weeks, each serving taken right before breakfast and lunch. |
| Low-fat milk | Placebo comparator | Dietary Supplement: Low-fat milkDaily consumption of two servings of 273 ml of low-fat milk (without plant sterols) for consecutive 3 weeks, each serving taken right before breakfast and lunch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Southern Chinese male or female ≥ 18years.
- In good general health as evidenced by medical history
- Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and discloser of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form
Key exclusion criteria (12 listed)
- Subject with familial hypercholesterolemia
- Ingestion of drugs known to interfere with lipid profiles, such as hormone replacement treatment, diuretics, beta-blockers, statin or other hypochoelsterolemic drug treatment
- Smoking > 10 cigarettes/day
- Subject with heavy alcohol intake (Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day)
- Having milk intolerance or dislike
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 |
|---|---|---|
| Plant sterols-enriched low-fat milkThe study product is a dried partly skimmed milk powder with no more than 12% milk fat (11.4g total fat/100g product) containing unesterified, unhydrogenated plant sterols. | Dietary supplement | Plant sterols-enriched low-fat milk |
| Low-fat milkThe placebo product is a dried partly skimmed milk powder. | Dietary supplement | Low-fat milk |
Primary outcome
Mean of serum low-density lipoprotein cholesterol (LDL-C)
Time frame: From baseline to week 3
6 secondary outcomes
Change of serum LDL-C
Time frame: From baseline to week 3
Change of high-density lipoprotein cholesterol (HDL-C)
Time frame: From baseline to week 3
Change of total cholesterol
Time frame: From baseline to week 3
Change of triglycerides (TAG)
Time frame: From baseline to week 3
Change of serum creatinine
Time frame: From baseline to week 3
Changes of fasting blood glucose
Time frame: From baseline to week 3
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 Oct 2015.
- Derived from this study: PubMed 28117400Cheung CL, Ho DK, Sing CW, Tsoi MF, Cheng VK, Lee GK, Ho YN, Cheung BM. Randomized controlled trial of the effect of phytosterols-enriched low-fat milk on lipid profile in Chinese. Sci Rep. 2017 Jan 24;7:41084. doi: 10.1038/srep41084.
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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.
Cheung Bernard Man Yung principal investigator
Li Ka Shing Faculty of Medicine, The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plant sterols-enriched low-fat milk and Low-fat milk in people with Dyslipidemia, run by The University of 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 3 inclusion and 12 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 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean of serum low-density lipoprotein cholesterol (LDL-C) (time frame: From baseline to week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02541201, which also lists 1 linked publication.
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 Oct 2015.