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

NCT04861545 | Active Not Recruiting

• 1 other identifier: Dupont - Soy protein/ISP
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiovascular disease; Coronary heart disease; LDL-Cholesterol; HDL-Cholesterol; Triglycerides; Apolipoprotein B; Soy protein; Isolated soy protein; Meta-analysis; Randomized controlled trial; Total Cholesterol

Outcome Measures

Primary Outcomes (1)

• Blood lipids - LDL-Cholesterol (LDL-C)

  LDL-C mean difference and 95%CIs in mmol/L

  ≥ 3 weeks

Secondary Outcomes (5)

• Blood lipids - HDL-Cholesterol (HDL-C)

  ≥ 3 weeks

• Blood lipids - Triglycerides (TG)

  ≥ 3 weeks

• Blood lipids - Total Cholesterol (TC)

  ≥ 3 weeks

• Blood lipids - Non-HDL-Cholesterol (Non-HDL-C)

  ≥ 3 weeks

• Blood lipids - Apolipoprotein B (Apo B)

  ≥ 3 weeks

Interventions

Soy OTHER

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).

Also known as: Isolated soy protein food sources, Non-Isolated soy protein food sources of soy protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with and without dyslipidemia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Sievenpiper: lead

Study Sites (1)

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, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Dyslipidemias; Cardiovascular Diseases; Coronary Disease

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• John L Sievenpiper, MD,PhD,FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

• David JA Jenkins, MD,DSc,FRSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Cyril WC Kendall, PhD

  University of Toronto

  STUDY CHAIR

• Alan Barclay, PhD

  University of Sydney

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)