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

NCT02541201 | Completed Phase 2 DMC

• 1 other identifier: CTC1430
• Study Type: interventional
• Target: 221
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Keywords

Plant sterols; Low-Density Lipoprotein Cholesterol; Phytosterols

Outcome Measures

Primary Outcomes (1)

• Mean of serum low-density lipoprotein cholesterol (LDL-C)

  From baseline to week 3

Secondary Outcomes (6)

• 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

Study Arms (2)

Plant sterols-enriched low-fat milk

EXPERIMENTAL

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

Low-fat milk

PLACEBO COMPARATOR

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

Interventions

Plant sterols-enriched low-fat milk 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.

Plant sterols-enriched low-fat milk

Low-fat milk DIETARY_SUPPLEMENT

The placebo product is a dried partly skimmed milk powder.

Low-fat milk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Related Publications (1)

• 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.

  PMID: 28117400 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Cheung Bernard Man Yung

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Chieh Yeh Heart Foundation Professor in Cardiovascular Therapeutics

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 4, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10