Your session is about to expire
← Back to Search
Other
Soy Milk for Metabolic Health
N/A
Recruiting
Led By John Sievenpiper, MD,PhD,FRCPC
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end value at week 24
Awards & highlights
Study Summary
This trial will assess the effect of using soy milk as a replacement for sugary drinks on liver fat and key cardiometabolic mediators/indicators in an at-risk population.
Who is the study for?
The STEM trial is for adults aged 18-75 who are overweight or obese with a BMI of 27-45 and have metabolic syndrome, including high waist circumference and dysglycemia. Participants should be regular consumers of sugar-sweetened beverages but not smokers or users of certain medications that affect the study's outcomes. Pregnant women, those planning dietary changes, and individuals with various health conditions like uncontrolled thyroid issues or recent major surgery are excluded.Check my eligibility
What is being tested?
This trial tests whether replacing sugar-sweetened beverages with soy milk instead of cow's milk can improve liver fat levels and other indicators related to obesity and diabetes. It's a randomized controlled trial comparing the effects of using 2% soy milk versus 2% cow's milk in an at-risk population.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, participants may experience digestive discomfort due to lactose intolerance if they consume cow’s milk. Soy milk could cause bloating or allergic reactions in some people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end value at week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end value at week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Liver fat
Secondary outcome measures
Beta-cell function
Glucose tolerance - 2-hour plasma glucose (2h-PG)
Glucose tolerance - plasma glucose AUC
+1 moreOther outcome measures
Adherence biomarkers - Objective biomarker of soy milk
Adherence biomarkers - Objective biomarkers of SSBs (13C/12C ratios in serum fatty acids)
Adherence biomarkers - Objective biomarkers of SSBs (urinary fructose)
+34 moreTrial Design
3Treatment groups
Active Control
Group I: 2% Cow's MilkActive Control1 Intervention
Participants will be asked to substitute their regular sugar sweetened beverage with the 2% cow's milk (up to a maximum of 6 servings/day)
Group II: 2% Soy MilkActive Control1 Intervention
Participants will be asked to substitute their regular sugar sweetened beverage with the 2% soy milk (up to a maximum of 6 servings/day)
Group III: Usual Sugar Sweetened BeverageActive Control1 Intervention
Participants will be asked to continue drinking their regular sugar sweetened beverage
Find a Location
Who is running the clinical trial?
United Soybean BoardUNKNOWN
1 Previous Clinical Trials
80 Total Patients Enrolled
University of TorontoLead Sponsor
689 Previous Clinical Trials
1,018,457 Total Patients Enrolled
22 Trials studying Metabolic Syndrome
772 Patients Enrolled for Metabolic Syndrome
John Sievenpiper, MD,PhD,FRCPCPrincipal InvestigatorUniversity of Toronto
2 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
1 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cystic fibrosis.I have been diagnosed with polycystic ovarian syndrome.I have a long-term lung condition.You use drugs for fun on a regular basis.I have been diagnosed with lipodystrophy.I have been diagnosed with a schizophrenia spectrum, bipolar, or dissociative disorder.My thyroid condition is not under control.I have not had major surgery in the past 6 months.I have lost 10% or more of my weight in the past 6 months.I have had weight loss surgery.I am overweight or obese with MetS, including high waist size and blood sugar.I am between 18 and 75 years old and not pregnant.I have Wilson's disease.I have a genetic disorder that affects my metabolism.I do not have any current infections like COVID-19, salmonella, HIV, or TB.You are planning to change your diet or exercise habits during the study.I am not taking any medications that could interfere with the study results.I have a condition affecting my digestive system like Crohn's or a problem absorbing nutrients.I have coeliac disease.I have been diagnosed with Cushing syndrome or disease.You cannot have an MRI scan if you have a pacemaker, neurostimulators, breast tissue expanders, implants, any metal objects in your body, or if you are claustrophobic.My blood pressure is not higher than 180/110 mmHg.You drink more than 3 alcoholic drinks every day.I have been diagnosed with polycystic ovarian syndrome.I have not had cancer in the last 6 months, except for skin cancer.I have acute kidney injury or severe chronic kidney disease.You are using alternative medicine that the researchers don't think is suitable for the study.You drink sugary drinks like sodas, sweetened teas, or energy drinks three or more times a day.I have had surgery to remove part of my colon or small intestine.You smoke tobacco regularly.I have been diagnosed with hypopituitarism.You are allergic to cow's milk or soy.I have severe depression.I have been diagnosed with haemochromatosis.I have chronic pancreatitis or my pancreas does not work properly.I have a long-term inflammatory condition.I have diabetes.I have heart disease related to artery blockage.I do not have any major illnesses besides my current condition.The participant has a condition where the sex glands produce little or no hormones.I have a liver condition such as fatty liver, cirrhosis, liver cancer, hepatitis, or a genetic liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: 2% Cow's Milk
- Group 2: 2% Soy Milk
- Group 3: Usual Sugar Sweetened Beverage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are enrolling in this experiment?
"That is correct. The listing on clinicaltrials.gov says that the trial is open and looking for participants. The study was first advertised on November 2nd 2021 and was last updated on January 13th 2022. They are looking to enroll 186 patients at a single site."
Answered by AI
For which type of patients is this research applicable?
"This study is enrolling 186 people with dyslipidemias aged 18 and 75. Most notable, patients must meet the following criteria: Overweight or obese (BMI 27-45 kg/m2) with MetS based on modified, Adults (age 18-75 years), men and non-pregnant women."
Answered by AI
Could you tell me if the cutoff age for this experiment is 55 years old?
"The minimum age limit to qualify for this clinical trial is 18, while the maximum age limit is set at 75."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger