NCT04861545Active, not recruiting
Meta-analyses of Soy Protein and Its Food Sources for Cholesterol Reduction
Effect of Soy Protein and Its Food Sources on Established Therapeutic Blood Lipid Targets: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1 (estimated)
- First submitted
- 22 Apr 2021
- Start date
- 1 May 2021
- Primary completion date
- 15 May 2028
- Lead sponsor
- John Sievenpiper
- Diseases
- Coronary artery disease
- NCT number
- NCT04861545
What you commit to
- Study type: Observational
- Planned participants: 1
- From 1 May 2021 to the primary completion date, 15 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Participants \<18 years of age
Other
- Non-human studies
- Observational studies
- Acute single-bolus feeding studies
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.