The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C

NCT02881658 | Completed Results DMC

• 1 other identifier: CTC1521
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage enriched with plant sterol for 3 weeks. This study also examines if there is other health-benefits by consuming the plant sterols fortified soya beverage in terms of serum total triglyceride, total and HDL cholesterol, other cardiometabolic risk factors and musculoskeletal-related traits including handgrip strength, gait speed, peak expiratory flow rate, bio-impedance and body balance.

Conditions

Dyslipidemia

Keywords

Plant sterols; Low-Density Lipoprotein Cholesterol; Phytosterols; Soya Beverage

Outcome Measures

Primary Outcomes (1)

• Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3

  From baseline to week 3

Secondary Outcomes (14)

• Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3

  From baseline to week 3

• Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3

  From baseline to week 3

• Change of Total Cholesterol Via Blood Test at Baseline and Week 3

  From baseline to week 3

• Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3

  From baseline to week 3

• Change of Serum Creatinine Via Blood Test at Baseline and Week 3

  From baseline to week 3

Study Arms (2)

Plant sterols-enriched soya beverage provided by Vitasoy

EXPERIMENTAL

Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).

Dietary Supplement: Plant sterols-enriched soya beverage provided by Vitasoy

Soya beverage provided by Vitasoy

PLACEBO COMPARATOR

Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).

Dietary Supplement: Soya beverage provided by Vitasoy

Interventions

Plant sterols-enriched soya beverage provided by Vitasoy DIETARY_SUPPLEMENT

the study product is a 2g plant sterols-enriched in 250ml soya beverage

Plant sterols-enriched soya beverage provided by Vitasoy

Soya beverage provided by Vitasoy DIETARY_SUPPLEMENT

the placebo product is a 250 ml soya beverage

Soya beverage provided by Vitasoy

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 ≥ 18 years;
• 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 disclose 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;
• On regular medication(s) which affect gastrointestinal functions and blood lipids level for the past 3 months, such as, but not limited to:
• Antibiotics of \>1 week duration
• GI related medications such as antacids
• Having blood lipid lowering medications such as statins, selective cholesterol absorption inhibitors (e.g. ezetimibe), fibrates, niacin, resins, omega- 3
• Heavy-smokers (more than 1 pack per day)
• Subject with heavy alcohol intake (\>40 g/day for men ; \>30 g/day for women) (32), or having history of alcohol abuse within 12 months prior to the study
• Subjects with taste aversion to placebo/intervention soya beverages
• Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product) or having regular consumption of sterols/stanols cholesterol-lowering supplements/functional foods or other related products such as:
• Sterol/ Stanol - containing margarines, milk, yoghurt drink and soya beverages
• Sterol / Stanol supplements
• Fish oils \& omega-3 supplements
• Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
• Pregnancy or lactation
• Having soy allergy

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Related Publications (1)

• Chau YP, Cheng YC, Sing CW, Tsoi MF, Cheng VK, Lee GK, Cheung CL, Cheung BMY. The lipid-lowering effect of once-daily soya drink fortified with phytosterols in normocholesterolaemic Chinese: a double-blind randomized controlled trial. Eur J Nutr. 2020 Sep;59(6):2739-2746. doi: 10.1007/s00394-019-02119-w. Epub 2019 Oct 23.

  PMID: 31642984 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr Cheung Ching Lung
• Organization: The University of Hong Kong

lung1212@hku.hk

(852)28315085

Study Officials

• Bernard Man Yung Cheung

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Medicine, HKU

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 29, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 3, 2018
• Results First Posted: September 21, 2017

Record last verified: 2018-05

Locations

HK (1)