CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 1 target
Drug / intervention
Soy milkother
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/NCT05637866
NCT05637866N/AUnknown

Effect of Soy Milk for Cow's Milk on Intermediate Cardiometabolic Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

University of Toronto·observational·Posted Dec 5, 2022·Updated Mar 6, 2023

In Brief

An observational study evaluating Soy milk for Cardiovascular Diseases and 3 related conditions. Targeting 1 participant across 1 site.

Detailed Summary

Dairy consumption has shown associations with decreased incidence of cardiometabolic diseases. With the growing interest in plant-based eating, and the mounting evidence for the cardiovascular benefits of plant forward diets, national dietary guidelines have pivoted away from promoting exclusive daily dairy consumption. Soymilk is the most nutritionally comparable non-dairy plant-based alternative to cow's milk. Although the DGA, Health Canada, and various pediatric associations recognize fortified soymilk as the only non-dairy alternative equivalent to cow's milk and it can carry an approved health claim for coronary heart disease risk reduction based on the soy protein that it contains, soymilk is classified by the NOVA classification as an ultra-processed food (the opposite of the classification of cow's milk as an unprocessed or minimally processed food). To be an acceptable iso-sweet alternative to cow's milk, soymilk is also often sweetened with sucrose, which is designated as an added sugar, whereas the lactose that sweetens cow's milk is not (despite lactose in cow's milk being present in quantities that are double that of sucrose in soymilk products designed to be iso-sweet analogues of cow's milk). With near universal recommendations from major public health authorities to reduce the intake of both ultra-processed foods and added sugars and the FDA proposing to update its "healthy" claim criteria to limit added sugars, the role of soymilk as a "healthy" non-dairy alternative to cow's milk is in serious question. The effect of soy protein on other cardiometabolic outcomes is also unclear. To address this question and better inform health claims and guideline development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein as soy milk, in substitution for cow's milk, on various intermediate cardiometabolic mediators.

Study Details

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

Timeline

N/AUnknownOverdue
2023202420252026
First PostedDec 5, 2022
Enrollment StartOct 1, 2022
Primary CompletionMar 30, 2023
Study CompletionOct 1, 2023
TodayJul 1, 2026
Enrollment to primary: 6 monthsPosted 3.6 years ago

Interventions

Soy milkother

Soya milk or soymilk, a plant-based beverage that can be sweetened or unsweetened.