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Soy Milk for Metabolic Health

N/A

Waitlist Available

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

Must not have

Cystic fibrosis

Chronic lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end value at week 24

Awards & highlights

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cystic fibrosis.

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I have a long-term lung condition.

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I have been diagnosed with lipodystrophy.

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I have been diagnosed with a schizophrenia spectrum, bipolar, or dissociative disorder.

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My thyroid condition is not under control.

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I have not had major surgery in the past 6 months.

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I have lost 10% or more of my weight in the past 6 months.

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I have had weight loss surgery.

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I have Wilson's disease.

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I have a genetic disorder that affects my metabolism.

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I do not have any current infections like COVID-19, salmonella, HIV, or TB.

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I have a condition affecting my digestive system like Crohn's or a problem absorbing nutrients.

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I have coeliac disease.

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I have been diagnosed with Cushing syndrome or disease.

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My blood pressure is not higher than 180/110 mmHg.

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I have not had cancer in the last 6 months, except for skin cancer.

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I have acute kidney injury or severe chronic kidney disease.

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I have had surgery to remove part of my colon or small intestine.

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I have been diagnosed with hypopituitarism.

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I have severe depression.

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I have been diagnosed with haemochromatosis.

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I have chronic pancreatitis or my pancreas does not work properly.

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I have diabetes.

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I have heart disease related to artery blockage.

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I have a liver condition such as fatty liver, cirrhosis, liver cancer, hepatitis, or a genetic liver disease.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and end value at week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Liver fat

Secondary study objectives

Beta-cell function

Glucose tolerance - 2-hour plasma glucose (2h-PG)

Glucose tolerance - plasma glucose AUC

+1 more

Other study objectives

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 more

Trial 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

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

United Soybean BoardUNKNOWN

1 Previous Clinical Trials

80 Total Patients Enrolled

University of TorontoLead Sponsor

705 Previous Clinical Trials

1,021,365 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

Soy Milk (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05191160 — N/A

Metabolic Syndrome Research Study Groups: 2% Cow's Milk, 2% Soy Milk, Usual Sugar Sweetened Beverage

Metabolic Syndrome Clinical Trial 2023: Soy Milk Highlights & Side Effects. Trial Name: NCT05191160 — N/A

Soy Milk (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05191160 — N/A

~5 spots leftby Oct 2024

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