MedTrace Logo

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

NCT04861545 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2026-02-13

No results posted yet for this 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.

Conditions

  • Dyslipidemias
  • Cardiovascular Risk Factor
  • Dysglycemia

Interventions

OTHER

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).

Sponsors & Collaborators

  • John Sievenpiper

    lead OTHER

Principal Investigators

  • John L Sievenpiper, MD,PhD,FRCPC · University of Toronto

  • David JA Jenkins, MD,DSc,FRSC · University of Toronto

  • Cyril WC Kendall, PhD · University of Toronto

  • Alan Barclay, PhD · University of Sydney

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2028-05-15
Completion
2028-05-15

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04861545 on ClinicalTrials.gov