Clinical trial NCT02541201: The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Keywords: Plant sterols
Low-Density Lipoprotein Cholesterol
Phytosterols
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mean of serum low-density lipoprotein cholesterol (LDL-C)
timeFrame: From baseline to week 3
Secondary outcomes:
measure: Change of serum LDL-C
timeFrame: From baseline to week 3
measure: Change of high-density lipoprotein cholesterol (HDL-C)
timeFrame: From baseline to week 3
measure: Change of total cholesterol
timeFrame: From baseline to week 3
measure: Change of triglycerides (TAG)
timeFrame: From baseline to week 3
measure: Change of serum creatinine
timeFrame: From baseline to week 3
measure: Changes of fasting blood glucose
timeFrame: From baseline to week 3
Other outcomes:
Locations:
Study officials:
affiliation: Li Ka Shing Faculty of Medicine, The University of Hong Kong
name: Cheung Bernard Man Yung
role: PRINCIPAL_INVESTIGATOR
References:
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.