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

NCT05637866 | Unknown

• 1 other identifier: CIHR - Soy vs cow's milk
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Cardiovascular Diseases; Lipid Disorder; Metabolic Disease; Non-Alcoholic Fatty Liver Disease

Keywords

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

Outcome Measures

Primary Outcomes (28)

• Blood lipids - LDL-Cholesterol (LDL-C)

  LDL-C mean difference and 95% CIs in mmol/L

  Immediately after the intervention

• Blood lipids - HDL-Cholesterol (HDL-C)

  HDL-C mean difference and 95% CIs in mmol/L

  Immediately after the intervention

• Blood lipids - Triglycerides (TG)

  TG mean difference and 95% CIs in mmol/L

  Immediately after the intervention

• Blood lipids - non-HDL-Cholesterol (Non HDL-C)

  Non-HDL-C mean difference and 95% CIs in mmol/L

  Immediately after the intervention

• Blood lipids - Apolipoprotein B (ApoB)

  ApoB mean difference and 95% CIs in g/L

  Immediately after the intervention

• Glycemic control - Hemoglobin A1c (HbA1c)

  HbA1c mean difference and 95% CIs in %

  Immediately after the intervention

• Glycemic control - fasting plasma glucose (FPG)

  FPG mean difference and 95% CIs in mmol/L

  Immediately after the intervention

• Glycemic control - fasting plasma insulin (FPI)

  FPI mean difference and 95% CIs in mmol/L

  Immediately after the intervention

• Glycemic control - glucose tolerance - plasma glucose area under the curve (AUC)

  AUC mean difference and 95% CIs in mmol x min/l

  Immediately after the intervention

• Glycemic control - glucose tolerance - 2h plasma glucose (2h-PG)

  2h plasma glucose (2h-PG) during a 75g oral glucose tolerance test (OGTT) in mmol/L

  Immediately after the intervention

• Adiposity - Body weight

  Body weight mean difference and 95% CIs in kg

  Immediately after the intervention

• Adiposity - Body mass index (BMI)

  BMI mean difference and 95% CIs in kg/m2

  Immediately after the intervention

• Adiposity - Body fat

  Body fat mean difference and 95% CIs in %

  Immediately after the intervention

• Adiposity - Waist circumference

  Waist circumference mean difference and 95% CIs in cm

  Immediately after the intervention

• Blood pressure - systolic blood pressure (SBP)

  SBP mean difference and 95% CIs in mmHg

  Immediately after the intervention

• Blood pressure - diastolic blood pressure (DBP)

  DBP mean difference and 95% CIs in mmHg

  Immediately after the intervention

• Markers of non-alcoholic fatty liver disease (NAFLD) - Intrahepatocellular lipids (IHCL)

  IHCL mean difference and 95% CIs in %

  Up to 20 years

• Markers of non-alcoholic fatty liver disease (NAFLD) - alanine transaminase (ALT)

  ALT mean difference and 95% CIs in U/L

  Immediately after the intervention

• Markers of non-alcoholic fatty liver disease (NAFLD) - aspartate aminotransferase (AST)

  AST mean difference and 95% CIs in U/L

  Immediately after the intervention

• Markers of non-alcoholic fatty liver disease (NAFLD) - fatty liver index (FLI)

  FLI mean difference and 95% CIs

  Immediately after the intervention

• Markers of inflammation - C-reactive protein (CRP)

  CRP mean difference and 95% CIs in mg/dL

  Immediately after the intervention

• Renal function and structure - creatinine

  Creatinine mean difference and 95% CIs in mcmol/L

  Immediately after the intervention

• Renal function and structure - creatinine clearance (CrCl)

  CrCl mean difference and 95% CIs in mL/min

  Immediately after the intervention

• Renal function and structure - glomerular filtration rate (GFR)

  GFR mean difference and 95% CIs in ml/min/1.73 m2

  Immediately after the intervention

• Renal function and structure - estimated GFR (eGFR)

  eGFR mean difference and 95% CIs in ml/min/1.73 m2

  Immediately after the intervention

• Renal function and structure - albumin excretion rate (AER)

  AER mean difference and 95% CIs in mg/L

  Immediately after the intervention

• Renal function and structure - albumin-to-creatinine ratio (ACR)

  ACR mean difference and 95% CIs in mg/mmol creatinine

  Immediately after the intervention

• Uric acid

  Uric acid in mcmol/L

  Immediately after the intervention

Study Arms (1)

Soy Milk

Soy milk beverage

Other: Soy milk

Interventions

Soy milk OTHER

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

Soy Milk

Eligibility Criteria

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

Study Population

Adults with or without cardiovascular risk factors

You may qualify if:

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

You may not qualify if:

• 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

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

Related Publications (4)

• Malik VS, Sun Q, van Dam RM, Rimm EB, Willett WC, Rosner B, Hu FB. Adolescent dairy product consumption and risk of type 2 diabetes in middle-aged women. Am J Clin Nutr. 2011 Sep;94(3):854-61. doi: 10.3945/ajcn.110.009621. Epub 2011 Jul 13.

  PMID: 21753066 BACKGROUND

• Maersk M, Belza A, Stodkilde-Jorgensen H, Ringgaard S, Chabanova E, Thomsen H, Pedersen SB, Astrup A, Richelsen B. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study. Am J Clin Nutr. 2012 Feb;95(2):283-9. doi: 10.3945/ajcn.111.022533. Epub 2011 Dec 28.

  PMID: 22205311 BACKGROUND

• McGregor RA, Poppitt SD. Milk protein for improved metabolic health: a review of the evidence. Nutr Metab (Lond). 2013 Jul 3;10(1):46. doi: 10.1186/1743-7075-10-46.

  PMID: 23822206 BACKGROUND

• Erlich MN, Ghidanac D, Blanco Mejia S, Khan TA, Chiavaroli L, Zurbau A, Ayoub-Charette S, Almneni A, Messina M, Leiter LA, Bazinet RP, Jenkins DJA, Kendall CWC, Sievenpiper JL. A systematic review and meta-analysis of randomized trials of substituting soymilk for cow's milk and intermediate cardiometabolic outcomes: understanding the impact of dairy alternatives in the transition to plant-based diets on cardiometabolic health. BMC Med. 2024 Aug 22;22(1):336. doi: 10.1186/s12916-024-03524-7.

  PMID: 39169353 DERIVED

Related Links

• Canada's Food Guide

MeSH Terms

Conditions

Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Non-alcoholic Fatty Liver Disease; Body Weight; Obesity; Fatty Liver; Inflammation

Interventions

Soy Milk

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food; 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 5, 2022
• Study Start: October 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: October 1, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)