NCT02541201

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Low-fat milk	The placebo product is a dried partly skimmed milk powder.

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-09-04
• Last updated: 2015-10-14