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Dairy Products for Heart Health
N/A
Recruiting
Led By Alice H Lichtenstein, D. Sc.
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >50 years
Men and postmenopausal women
Must not have
Alcohol consumption >7 drinks/week for women and >14 drinks/week for men
Inadequate refrigerator storage capacity to store 21 8-oz containers of milk or yogurt
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how regular/skim milk & full-fat/fat-free yogurt affect gut bacteria & heart health risk factors. Results may help refine dietary guidance for CVD risk reduction.
Who is the study for?
This trial is for men and postmenopausal women over 50 with a BMI between 25-35, who don't smoke, have regular bowel movements, and are not on certain medications. Excluded are those underweight or overweight beyond the set limits, recent smokers or nicotine users, hormone therapy recipients, anemia patients within two years, recent blood donors or antibiotic users.
What is being tested?
The study tests how full-fat and fat-free milk and yogurt affect gut microbes and heart disease risk factors. Participants will consume these dairy products to see if fat content and fermentation influence cardiovascular health.
What are the potential side effects?
Potential side effects may include changes in digestion due to different fat contents in dairy products. Full-fat options might impact cholesterol levels more than fat-free ones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 50 years old.
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I am a man or a woman who has gone through menopause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I drink more than the recommended amount of alcohol weekly.
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I don't have enough fridge space for 21 milk or yogurt containers.
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I regularly take medication to lower stomach acid more than twice a week.
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I have diabetes.
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I have a long-term heart, liver, thyroid, or kidney disease.
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I am currently smoking or quit less than 6 months ago.
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I am currently on hormone replacement or gender affirming therapy.
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I have high blood pressure that hasn't been treated.
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I am not willing or able to follow the study rules.
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I am a woman who has not gone through menopause.
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I am younger than 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
fecal metabolome
gut microbiome
serum metabolome
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Full-fat yogurt beverageExperimental Treatment1 Intervention
Beverage made with full-fat yogurt
Group II: Full-fat milk beverageExperimental Treatment1 Intervention
Beverage made with full-fat milk
Group III: Fat-free yogurt beverageExperimental Treatment1 Intervention
Beverage made with fat-free yogurt
Group IV: Fat-free milk beverageExperimental Treatment1 Intervention
Beverage made with fat-free milk
Find a Location
Who is running the clinical trial?
Tufts UniversityLead Sponsor
270 Previous Clinical Trials
596,098 Total Patients Enrolled
Alice H Lichtenstein, D. Sc.Principal InvestigatorTufts University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken oral antibiotics in the last 2 weeks.You have donated blood in the last 2 months.I am over 50 years old.Your body mass index (BMI) is between 25 and 35.I have a chronic gastrointestinal condition that could affect the study.I drink more than the recommended amount of alcohol weekly.You have regular bowel movements at least every other day.I don't have enough fridge space for 21 milk or yogurt containers.I regularly take medication to lower stomach acid more than twice a week.I have not used steroids recently, except for over-the-counter creams or nasal sprays.I have diabetes.I am a man or a woman who has gone through menopause.I have a long-term heart, liver, thyroid, or kidney disease.You had low levels of red blood cells in the past 2 years or have low levels at the start of the study.I am currently smoking or quit less than 6 months ago.You have used nicotine replacement products in the last 6 months.I am currently on hormone replacement or gender affirming therapy.I have high blood pressure that hasn't been treated.I have had a colonoscopy within the last 3 weeks or will have one during the study.I am not willing or able to follow the study rules.Your body mass index (BMI) is less than 25 or greater than 35.I am a woman who has not gone through menopause.I regularly use aspirin, NSAIDs, laxatives, or anti-diarrheal medication.I am younger than 50 years old.You have gained more than 15 pounds in the last 6 months.I experience infrequent bowel movements.You do not smoke.I am taking medication to lower my cholesterol.
Research Study Groups:
This trial has the following groups:- Group 1: Fat-free milk beverage
- Group 2: Fat-free yogurt beverage
- Group 3: Full-fat yogurt beverage
- Group 4: Full-fat milk 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.
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