Meta-analysis of 46 FDA Identified Studies on Lipid Markers
A Meta-analysis of 46 Studies Identified by the FDA on the Effect of Soy Protein on Lipid Markers (LDL-Cholesterol [LDL-C] and Total Cholesterol [TC]) as Surrogates of Cardiovascular Disease
1 other identifier
observational
1
1 country
2
Brief Summary
The FDA have revised the data on soy and concluded that a heart health claim is no longer justified based on more recent studies. They are allowing and established panel for public input. The selected studies have not been meta-analyzed, therefore we will conduct a meta-analysis of the 46 FDA selected studies to assess the effect of soy protein on surrogate markers of cardiovascular disease (LDL-C and TC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2018
CompletedFirst Submitted
Initial submission to the registry
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedMarch 16, 2018
March 1, 2018
1 month
March 9, 2018
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surrogate lipid markers of CVD
LDL-Cholesterol (LDL-C) Total Cholesterol (TC)
Long term (>3weeks)
Interventions
Isolated soy protein, soy protein, soybean products, soy milk
Eligibility Criteria
All individuals, regardless of health status
You may qualify if:
- Studies pre-identified by the FDA \[Docket No. FDA-2017-N-0763\]
You may not qualify if:
- Studies with no viable outcome data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, M5C 2T2, Canada
University of Toronto
Toronto, Ontario, M5S 3E2, Canada
Related Publications (1)
Blanco Mejia S, Messina M, Li SS, Viguiliouk E, Chiavaroli L, Khan TA, Srichaikul K, Mirrahimi A, Sievenpiper JL, Kris-Etherton P, Jenkins DJA. A Meta-Analysis of 46 Studies Identified by the FDA Demonstrates that Soy Protein Decreases Circulating LDL and Total Cholesterol Concentrations in Adults. J Nutr. 2019 Jun 1;149(6):968-981. doi: 10.1093/jn/nxz020.
PMID: 31006811DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David J Jenkins, MD, PhD, DSc
University of Toronto
- PRINCIPAL INVESTIGATOR
John L Sievenpiper, MD, PhD, FRCPC
University of Toronto
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 9, 2018
First Posted
March 16, 2018
Study Start
March 7, 2018
Primary Completion
April 19, 2018
Study Completion
May 31, 2018
Last Updated
March 16, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
All data will be published