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The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (COME-PASS) (COME-PASS)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Plant sterols-enriched low-fat milk
Low-fat milk
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyslipidemia focused on measuring Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Plant sterols-enriched low-fat milk

    Low-fat milk

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Mean of serum low-density lipoprotein cholesterol (LDL-C)

    Secondary Outcome Measures

    Change of serum LDL-C
    Change of high-density lipoprotein cholesterol (HDL-C)
    Change of total cholesterol
    Change of triglycerides (TAG)
    Change of serum creatinine
    Changes of fasting blood glucose

    Full Information

    First Posted
    August 26, 2015
    Last Updated
    October 12, 2015
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02541201
    Brief Title
    The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (COME-PASS)
    Acronym
    COME-PASS
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia
    Keywords
    Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    221 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Plant sterols-enriched low-fat milk
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Low-fat milk
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Plant sterols-enriched low-fat milk
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Low-fat milk
    Intervention Description
    The placebo product is a dried partly skimmed milk powder.
    Primary Outcome Measure Information:
    Title
    Mean of serum low-density lipoprotein cholesterol (LDL-C)
    Time Frame
    From baseline to week 3
    Secondary Outcome Measure Information:
    Title
    Change of serum LDL-C
    Time Frame
    From baseline to week 3
    Title
    Change of high-density lipoprotein cholesterol (HDL-C)
    Time Frame
    From baseline to week 3
    Title
    Change of total cholesterol
    Time Frame
    From baseline to week 3
    Title
    Change of triglycerides (TAG)
    Time Frame
    From baseline to week 3
    Title
    Change of serum creatinine
    Time Frame
    From baseline to week 3
    Title
    Changes of fasting blood glucose
    Time Frame
    From baseline to week 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheung Bernard Man Yung
    Organizational Affiliation
    Li Ka Shing Faculty of Medicine, The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28117400
    Citation
    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.
    Results Reference
    derived

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    The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (COME-PASS)

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