SRMA of the Effect of Soy Protein on Blood Pressure

NCT05638061 | Active Not Recruiting

• 1 other identifier: CIHR - Soy and BP
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is one of the leading risk factors for death and significantly increases the risk for cardiovascular (CVD), brain and kidney diseases. It is also one of the leading modifiable risk factors for CVD, which also plays a significant role in the global burden of death and disease. Dietary guidelines for blood pressure management and hypertension emphasize fruits and vegetables, plant-based proteins and foods low in saturated fat. With the growing interest in plant-based alternatives and plant-based diets, there is a need to clarify their benefits on blood pressure. Soy protein is a complete protein and is the only plant-based beverage alternative that is comparable to dairy milk. There are mixed findings on the effects of soy on blood pressure due to differences in study design and subjects. To better address this question and inform public health guidelines the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein on reducing blood pressure in individuals with and without hypertension.

Conditions

Blood Pressure; Cardiovascular Diseases

Keywords

systolic blood pressure; diastolic blood pressure; systematic review; meta-analysis; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure (SBP)

  SBP mean difference and 95% CIs in mmHg

  Immediately after the intervention

• Diastolic Blood Pressure (DBP)

  DBP mean difference and 95% CIs in mmHg

  Immediately after the intervention

Interventions

Soy protein OTHER

Soy foods or isolated soy protein

Also known as: Soya, soybean, soy bean, soya bean

Eligibility Criteria

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

Study Population

Adults with or without high blood pressure

You may qualify if:

• Randomized Controlled Trials
• Soy intervention
• Non-soy comparator
• Intervention duration \>3 weeks
• Data for \>1 Outcome

You may not qualify if:

• Observational Studies
• Non-Human Studies
• Lack of Suitable Comparator (i.e. soy-containing, equally matched doses)
• Multimodal interventions
• RCTs with participants \< 18 years of age

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• John L. Sievenpiper, MD,PhD,FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 6, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)