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SRMA of the Effect of Soy Milk vs Cow's Milk on Cardiometabolic Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05637866
Recruitment Status : Active, not recruiting
First Posted : December 5, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief 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. Soy milk, the most nutritionally comparable plant-based milk alternative to cow's milk, is a commonly consumed source of heart-healthy soy protein. Though the beneficial effect of soy protein on lipid markers is well established, the impact on other cardiometabolic outcomes is 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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Lipid Disorder Metabolic Disease Non-Alcoholic Fatty Liver Disease Other: Soy milk

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Other
Official Title: Effect of Soy Milk for Cow's Milk on Intermediate Cardiometabolic Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Soy Milk
Soy milk beverage
Other: Soy milk
Soya milk or soymilk, a plant-based beverage that can be sweetened or unsweetened.




Primary Outcome Measures :
  1. Blood lipids - LDL-Cholesterol (LDL-C) [ Time Frame: Immediately after the intervention ]
    LDL-C mean difference and 95% CIs in mmol/L

  2. Blood lipids - HDL-Cholesterol (HDL-C) [ Time Frame: Immediately after the intervention ]
    HDL-C mean difference and 95% CIs in mmol/L

  3. Blood lipids - Triglycerides (TG) [ Time Frame: Immediately after the intervention ]
    TG mean difference and 95% CIs in mmol/L

  4. Blood lipids - non-HDL-Cholesterol (Non HDL-C) [ Time Frame: Immediately after the intervention ]
    Non-HDL-C mean difference and 95% CIs in mmol/L

  5. Blood lipids - Apolipoprotein B (ApoB) [ Time Frame: Immediately after the intervention ]
    ApoB mean difference and 95% CIs in g/L

  6. Glycemic control - Hemoglobin A1c (HbA1c) [ Time Frame: Immediately after the intervention ]
    HbA1c mean difference and 95% CIs in %

  7. Glycemic control - fasting plasma glucose (FPG) [ Time Frame: Immediately after the intervention ]
    FPG mean difference and 95% CIs in mmol/L

  8. Glycemic control - fasting plasma insulin (FPI) [ Time Frame: Immediately after the intervention ]
    FPI mean difference and 95% CIs in mmol/L

  9. Glycemic control - glucose tolerance - plasma glucose area under the curve (AUC) [ Time Frame: Immediately after the intervention ]
    AUC mean difference and 95% CIs in mmol x min/l

  10. Glycemic control - glucose tolerance - 2h plasma glucose (2h-PG) [ Time Frame: Immediately after the intervention ]
    2h plasma glucose (2h-PG) during a 75g oral glucose tolerance test (OGTT) in mmol/L

  11. Adiposity - Body weight [ Time Frame: Immediately after the intervention ]
    Body weight mean difference and 95% CIs in kg

  12. Adiposity - Body mass index (BMI) [ Time Frame: Immediately after the intervention ]
    BMI mean difference and 95% CIs in kg/m2

  13. Adiposity - Body fat [ Time Frame: Immediately after the intervention ]
    Body fat mean difference and 95% CIs in %

  14. Adiposity - Waist circumference [ Time Frame: Immediately after the intervention ]
    Waist circumference mean difference and 95% CIs in cm

  15. Blood pressure - systolic blood pressure (SBP) [ Time Frame: Immediately after the intervention ]
    SBP mean difference and 95% CIs in mmHg

  16. Blood pressure - diastolic blood pressure (DBP) [ Time Frame: Immediately after the intervention ]
    DBP mean difference and 95% CIs in mmHg

  17. Markers of non-alcoholic fatty liver disease (NAFLD) - Intrahepatocellular lipids (IHCL) [ Time Frame: Up to 20 years ]
    IHCL mean difference and 95% CIs in %

  18. Markers of non-alcoholic fatty liver disease (NAFLD) - alanine transaminase (ALT) [ Time Frame: Immediately after the intervention ]
    ALT mean difference and 95% CIs in U/L

  19. Markers of non-alcoholic fatty liver disease (NAFLD) - aspartate aminotransferase (AST) [ Time Frame: Immediately after the intervention ]
    AST mean difference and 95% CIs in U/L

  20. Markers of non-alcoholic fatty liver disease (NAFLD) - fatty liver index (FLI) [ Time Frame: Immediately after the intervention ]
    FLI mean difference and 95% CIs

  21. Markers of inflammation - C-reactive protein (CRP) [ Time Frame: Immediately after the intervention ]
    CRP mean difference and 95% CIs in mg/dL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults with or without cardiovascular risk factors
Criteria

Inclusion Criteria:

  • Randomized controlled trials
  • Soy milk intervention
  • Cow's milk comparator
  • Intervention duration ≥ 3 weeks
  • Data for at least 1 outcome

Exclusion Criteria:

  • Non-human studies
  • Observational studies
  • Acute single-bolus feeding studies
  • Participants < 18 years of age
  • Multimodal interventions
  • Lack of suitable comparator
  • Intervention duration < 3 weeks
  • No viable outcome data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637866


Locations
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Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: John L. Sievenpiper, MD,PhD,FRCPC University of Toronto
Additional Information:
Publications:
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Responsible Party: John Sievenpiper, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT05637866    
Other Study ID Numbers: CIHR - Soy vs cow's milk
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no individual data collected. However, data from all included studies will be published in the manuscript and supplementary material

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Sievenpiper, University of Toronto:
Cholesterol
triglycerides
apolipoprotein B
hemoglobin A1c
fasting plasma glucose
fasting plasma insulin
2hr plasma glucose
body weight
body mass index
body fat
waist circumference
blood pressure
adiposity
fatty liver
NAFLD
CRP
Inflammation
HDL-C
LDL-C
Non-HDL-c
Intrahepatocellular lipids
ALT
AST
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Cardiovascular Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Digestive System Diseases