CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 1 target
Drug / intervention
Soy foodsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03468127
NCT03468127N/AUnknown

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

University of Toronto·observational·Posted Mar 16, 2018·Updated Mar 16, 2018

In Brief

An observational study evaluating Soy foods for Cardiovascular Diseases. Targeting 1 participant across 2 sites.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/AUnknownOverdue
201820192020202120222023202420252026
First PostedMar 16, 2018
Enrollment StartMar 7, 2018
Primary CompletionApr 19, 2018
Study CompletionMay 31, 2018
TodayJul 1, 2026
Enrollment to primary: 1 monthPosted 8.3 years ago

Interventions

Soy foodsother

Isolated soy protein, soy protein, soybean products, soy milk