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

Dyslipidemia Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541201
• Other study ID #: CTC1430
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2015
• Last updated: October 12, 2015
• Start date: August 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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.
• Low-fat milk
The placebo product is a dried partly skimmed milk powder.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of serum low-density lipoprotein cholesterol (LDL-C)		From baseline to week 3	No
Secondary	Change of serum LDL-C		From baseline to week 3	No
Secondary	Change of high-density lipoprotein cholesterol (HDL-C)		From baseline to week 3	No
Secondary	Change of total cholesterol		From baseline to week 3	No
Secondary	Change of triglycerides (TAG)		From baseline to week 3	No
Secondary	Change of serum creatinine		From baseline to week 3	No
Secondary	Changes of fasting blood glucose		From baseline to week 3	No