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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: Plant sterols-enriched low-fat milk; Dietary supplement: 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 Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plant sterols-enriched low-fat milk; 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.	Dietary supplement: Plant sterols-enriched low-fat milk; 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.
Placebo Comparator: Low-fat milk; 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.	Dietary supplement: Low-fat milk; The placebo product is a dried partly skimmed milk powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean of serum low-density lipoprotein cholesterol (LDL-C)	From baseline to week 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of serum LDL-C	From baseline to week 3
Change of high-density lipoprotein cholesterol (HDL-C)	From baseline to week 3
Change of total cholesterol	From baseline to week 3
Change of triglycerides (TAG)	From baseline to week 3
Change of serum creatinine	From baseline to week 3
Changes of fasting blood glucose	From baseline to week 3

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Cheung Bernard Man Yung, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 12, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Phytosterols; Plant sterols; Low-Density Lipoprotein Cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CTC1430