CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 1 target
Drug / intervention
Soyother
Likely dose
Not stated in record
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Search/NCT04861545
NCT04861545N/AActiveOn TrackUpdated 4mo ago

Effect of Soy Protein and Its Food Sources on Established Therapeutic Blood Lipid Targets: A Systematic Review and Meta-analysis of Randomized Controlled Trials

John Sievenpiper·observational·Posted Apr 27, 2021·Updated Feb 13, 2026

In Brief

An observational study evaluating Soy for Dyslipidemias and 2 related conditions. Active but no longer recruiting, targeting 1 participant across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/AActive
2022202320242025202620272028
First PostedApr 27, 2021
Enrollment StartMay 1, 2021
Primary CompletionMay 15, 2028
TodayJul 1, 2026
Enrollment to primary: 7.0 yearsPosted 5.2 years agoPrimary completion in 1.9 years

Interventions

Soyother

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).