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

NCT ID: NCT02541201

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-09-30

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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Plant sterols-enriched low-fat milk

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: PLACEBO_COMPARATOR

Low-fat milk

Intervention Type: DIETARY_SUPPLEMENT

The placebo product is a dried partly skimmed milk powder.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Low-fat milk

The placebo product is a dried partly skimmed milk powder.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Bernard Cheung

Sun Chieh Yeh Heart Foundation Professor in Cardiovascular Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheung Bernard Man Yung

Role: PRINCIPAL_INVESTIGATOR

Li Ka Shing Faculty of Medicine, The University of Hong Kong

References

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.

Reference Type: DERIVED

PMID: 28117400 (View on PubMed)

Other Identifiers

CTC1430

Identifier Type: -

Identifier Source: org_study_id