Dairy Fat and Fermentation Study
The purpose of the study is to compare the effect of consuming full-fat (regular) and fat-free (skim) milk, as well as full-fat and fat-free yogurt (a fermented dairy product), on microorganisms in your gut as well as the products produced by the gut microbes. We will also determine whether consuming these dairy products affects risk factors for heart disease.The findings of the study will help us determine if heart disease risk factors are modified by the fat content and fermentation of milk. The results may facilitate refinement of public health dietary guidance for cardiovascular disease risk reduction.
Conditions:
🦠 Heart Diseases 🦠 Microbial Colonization 🦠 Inflammation
🗓️ Study Start (Actual) 1 October 2023
🗓️ Primary Completion (Estimated) 1 December 2025
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age \>50 years
    • 2. Men and postmenopausal women
    • 3. BMI \>25 and \<35 kg/m2
    • 4. No milk allergy, lactose intolerance or adherence to vegan or other dietary pattern that excludes dairy products
    • 5. Non-smoker
    • 6. Usual pattern of bowel movements at least every other day.

    Exclusion Criteria:

    • 1. Women and men \<50 years
    • 2. Women, pre- or peri-menopausal
    • 3. BMI \<25 and \>35 kg/m2
    • 4. Current smokers or former smoker who quit \< 6 months
    • 5. Use of nicotine replacement products within last 6 months
    • 6. Replacement or gender affirming hormonal therapy use
    • 7. Weight gain of \>15 pounds within last 6 months
    • 8. Infrequent bowel movements
    • 9. History of anemia within past 2 years or confirmation of anemia at first study visit
    • 10. Blood donation within last 2 months
    • 11. Untreated hypertension
    • 12. Oral antibiotics use within 2 weeks of study entry
    • 13. Steroid use (including dental prophylaxis use within 2 wks prior to or during study, except non-prescription topical and nasal steroids, e. g. Flonase)
    • 14. Use of lipid lowering medications
    • 15. Chronic use of aspirin, non-steroidal anti-inflammatory medications (NSAIDS), laxatives, anti-diarrheal medication
    • 16. Regular use (\>2 times per week) of acid lowering medication: antacids, proton pump inhibitors, or H2 Blockers.
    • 17. Use of dietary supplements other than multi-vitamins, including pre- and probiotics, within 2 months of study entry
    • 18. Milk allergy, lactose intolerance or adherence to vegan or other dietary patterns that exclude dairy products
    • 19. Colonoscopy within 3 weeks of study entry or during study period
    • 20. Diagnosis of malabsorption, inflammatory bowel disease (ulcerative colitis or Crohn's Disease), cirrhosis, history of gastrointestinal resection (other than appendectomy), chronic pancreatitis or any other chronic GI disease that in the opinion of the study physician would alter the study results
    • 21. Chronic heart, liver, thyroid, renal or kidney disease
    • 22. Type I or type II diabetes
    • 23. Alcohol consumption \>7 drinks/week for women and \>14 drinks/week for men
    • 24. Inadequate refrigerator storage capacity to store 21 8-oz containers of milk or yogurt
    • 25. Participation in other dietary intervention research study during the same time
    • 26. No social security number
    • 27. Not willing to commit to adhering to the protocol
Ages Eligible for Study: 50 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 April 2023
  • First Submitted that Met QC Criteria 21 April 2023
  • First Posted 3 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 December 2023
  • Last Update Posted 19 December 2023
  • Last Verified December 2023