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Dairy Foods for Insulin Resistance
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Waitlist Available
Research Sponsored by Midwest Center for Metabolic and Cardiovascular Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is 18-74 years of age
Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures
Must not have
Subject has uncontrolled hypertension at screening
Subject has atherosclerotic cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trialaims to see how replacing non-dairy foods with either full-fat or low-fat dairy affects insulin sensitivity, fatty acids and cardiometabolic health in at-risk adults.
Who is the study for?
Adults aged 18-74 with a BMI of 25-39.99 and high fasting triglyceride levels who are in good health, can maintain their usual physical activity, avoid vigorous exercise before clinic visits, abstain from alcohol and marijuana use for 24 hours prior to visits, and follow dietary instructions for the study period. Exclusions include recent cancer survivors, those on unstable medication regimens affecting blood pressure or metabolism, extreme dieters or those with certain medical conditions.
What is being tested?
The trial is testing the impact of adding two servings per day of either full-fat or low-fat fermented dairy products compared to non-dairy foods on insulin sensitivity and other markers related to heart health and metabolism in adults at risk due to body weight or lipid profiles.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include digestive discomfort especially if participants have mild lactose intolerance (which is not an exclusion criterion), changes in appetite or weight due to diet alteration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 74 years old.
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I understand the study and agree to participate and share my health information.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is high and not under control.
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I have heart disease caused by hardening of the arteries.
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I haven't changed my blood pressure medication in the last 4 weeks.
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I have not used antibiotics or had an infection within the last 5 days.
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I am not pregnant, planning to be, lactating, or if capable of bearing children, I agree to use contraception during the study.
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I have been diagnosed with an eating disorder.
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I have diabetes or my fasting blood sugar is 126 mg/dL or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insulin Sensitivity
Secondary study objectives
Alternate Healthy Eating Index
Carbohydrate metabolism variables
Erythrocyte
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Full-fat fermented dairyExperimental Treatment1 Intervention
1 serving per day of full-fat yogurt and full-fat fermented cheese
Group II: Low-fat fermented dairyActive Control1 Intervention
1 serving per day of low-fat yogurt and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese).
Group III: Non-dairy, non-fermented foodsPlacebo Group1 Intervention
2 servings per day of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition.
Find a Location
Who is running the clinical trial?
Midwest Center for Metabolic and Cardiovascular ResearchLead Sponsor
21 Previous Clinical Trials
746 Total Patients Enrolled
2 Trials studying Hypertriglyceridemia
70 Patients Enrolled for Hypertriglyceridemia
National Dairy CouncilOTHER
19 Previous Clinical Trials
1,698 Total Patients Enrolled
Kevin Maki, PhDStudy DirectorMB Clinical Research & Consulting, LLC
12 Previous Clinical Trials
924 Total Patients Enrolled
1 Trials studying Hypertriglyceridemia
93 Patients Enrolled for Hypertriglyceridemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight has changed by about 10 pounds in the last 3 months.I am between 18 and 74 years old.I can understand and follow the study's requirements without any health issues interfering.My blood pressure is high and not under control.I have a health condition that could affect the study's outcome.I haven't changed my cholesterol medication in the last 4 weeks.I am willing to visit the clinic to pick up study-related food if required.I haven't consistently used a PCSK9 inhibitor in the last 3 months.I have heart disease caused by hardening of the arteries.My medication affecting blood sugar hasn't changed in the last 4 weeks.I haven't used weight-loss or systemic corticosteroid drugs in the last 4 weeks.I have not taken any experimental drugs in the last 30 days.I haven't changed my blood pressure medication in the last 4 weeks.I understand the study and agree to participate and share my health information.I have not used antibiotics or had an infection within the last 5 days.I have had cancer in the last 5 years, but not skin cancer or early-stage cervical cancer.I am not pregnant, planning to be, lactating, or if capable of bearing children, I agree to use contraception during the study.I have been diagnosed with an eating disorder.I can avoid marijuana and alcohol for 24 hours before clinic visits.I have diabetes or my fasting blood sugar is 126 mg/dL or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Low-fat fermented dairy
- Group 2: Non-dairy, non-fermented foods
- Group 3: Full-fat fermented dairy
Awards:
This trial has 0 awards, including: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.