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

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Dietary Supplement: Low-fat milk; Dietary Supplement: Plant sterols-enriched low-fat milk

• Registration Number: NCT02541201
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-26
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-fat milk	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.
Plant sterols-enriched low-fat milk	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.

Primary Outcome Measures

Name	Time	Method
Mean of serum low-density lipoprotein cholesterol (LDL-C)	From baseline to week 3

Secondary Outcome Measures

Name	Time	Method
Change of total cholesterol	From baseline to week 3
Change of triglycerides (TAG)	From baseline to week 3
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 serum creatinine	From baseline to week 3
Changes of fasting blood glucose	From baseline to week 3