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Clinical Trials in Canada / NCT04861545
Active, not recruiting Observational

Meta-analyses of Soy Protein and Its Food Sources for Cholesterol Reduction

NCT04861545 · tracked via the Priya Life Science Canada tracker
Sponsor
John Sievenpiper
Phase
Observational
Started
2021-05-01
Last updated
2026-02-13

Condition(s) studied

DyslipidemiasCardiovascular Risk FactorDysglycemia

Investigational drug(s) / intervention(s)

Soy

Soy: Isolated soy protein food sources are foods that include isolated soy protein in different forms and matrix (e.g. soy beverage and meat analogue). Non-isolated soy protein food sources of soy protein are foods made with soy (e.g. Tofu, tempeh, edamame).

Study summary

Although soy protein has approved health claims in Canada and the US, and is recognized by major cardiovascular clinical practice guidelines for the reduction of cholesterol and risk of coronary heart disease (CHD), these claims are based almost exclusively on evidence from foods containing isolated soy protein (ISP). The role of other non-ISP food sources of soy protein (e.g Tofu, tempeh, edamame) in these effects is unclear. The role of food form and matrix (e.g soy beverage versus meat analogue) on the effects of ISP is also unclear. As national dietary guidelines and clinical practice guidelines for nutrition therapy shift from a focus on single nutrients to a focus on foods and dietary patterns, it is important to understand whether non-ISP food sources of soy protein and ISP food sources with different food matrices produce the same reductions in LDL-cholesterol and CHD risk. To strengthen the evidence-base for health claims and guidelines development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of ISP and non-ISP food sources of soy protein on stablished lipid targets in individuals with and without dyslipidemia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Randomized controlled trials * Soy protein (Isolated soy protein and non-isolated soy protein) intervention * Non-soy protein containing comparator * Intervention duration ≥ 3 weeks * Data for at least 1 outcome Exclusion Criteria: * Non-human studies * Observational studies * Acute single-bolus feeding studies * Participants \<18 years of age * Interventions of soy derivatives or extracts (i.e. soy oil, sterols, etc) * No quantification of soy protein in intervention * Multimodal interventions * Lack of a suitable comparator (i.e. a comparator arm that contains soy protein) * Intervention duration \< 3 weeks * No viable outcome data

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Micheal's Hospital Toronto Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04861545 on ClinicalTrials.gov ↗ ← All trials in Canada