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Lipid-lowering agent
Milk Polar Lipids for Abdominal Obesity
Phase < 1
Recruiting
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 40 to 70 years
Be older than 18 years old
Must not have
Taking medications which primarily affect blood clotting (e.g., warfarin)
Taking anti-inflammatory medications (e.g., corticosteroids)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
This trial looks at how drinking milk affects heart health and metabolic diseases like diabetes.
Who is the study for?
This trial is for adults aged 40 to 70 with high LDL cholesterol (bad cholesterol) and a large waistline, indicating abdominal obesity. It's not suitable for individuals with gallbladder, thyroid, gut diseases, autoimmune or chronic inflammatory conditions, diabetes, recent antibiotic use, milk allergies/intolerances, or those on certain medications like statins.
What is being tested?
The study tests if consuming a dairy powder rich in milk polar lipids daily can improve heart health and reduce risk factors associated with heart disease in people with high cholesterol and abdominal obesity.
What are the potential side effects?
Potential side effects are not detailed but may include reactions typical of dairy consumption such as digestive discomfort especially for those who might have undiagnosed lactose intolerance or sensitivity to dairy components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medication that affects blood clotting.
Select...
I am currently taking anti-inflammatory medications.
Select...
I have scleroderma.
Select...
I am taking medication to lower my cholesterol.
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I have diabetes.
Select...
I have had a stroke.
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I have a blood clotting disorder.
Select...
I have heart disease.
Select...
I have kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline Serum LDL Cholesterol at 8 weeks
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MPL-rich dairy powderExperimental Treatment1 Intervention
Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.
Group II: Control dairy powderPlacebo Group1 Intervention
Daily consumption of 50 g of dairy powder containing \<0.1 g MPL for 8 weeks
Find a Location
Who is running the clinical trial?
Dairy Management Inc.Industry Sponsor
20 Previous Clinical Trials
2,446 Total Patients Enrolled
4 Trials studying Dyslipidemia
789 Patients Enrolled for Dyslipidemia
University of ConnecticutLead Sponsor
192 Previous Clinical Trials
160,750 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a thyroid condition.You are allergic or intolerant to milk products.You have an eating disorder.I am taking medication that affects blood clotting.I am currently taking anti-inflammatory medications.Your LDL cholesterol level is higher than 130 mg/dL.Your weight has changed by more than 10% in the last 4 weeks.I have taken oral antibiotics within the last month and may continue during the study.You have not yet gone through menopause.I have been diagnosed with cancer.Your blood has very high levels of triglycerides when you haven't eaten for a while.I have scleroderma.I am taking medication to lower my cholesterol.I have a gut-related health issue.You have an autoimmune disease.I have a long-term inflammatory condition.I have diabetes.I have a liver condition.I have had a stroke.I have a blood clotting disorder.Your blood sugar level when fasting is higher than 126 milligrams per deciliter.I have heart disease.You have used drugs by injecting them into your veins.Your waist measurement is 88 cm or more if you are a woman, or 102 cm or more if you are a man.I am between 40 and 70 years old.I have gallbladder disease.I have kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: MPL-rich dairy powder
- Group 2: Control dairy powder
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.