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Search / Trial NCT05840081

Dairy Fat and Fermentation Study

Launched by TUFTS UNIVERSITY · Apr 21, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Gut Microbiome Gut Microbiota Yogurt Milk Heart Disease

ClinConnect Summary

The Dairy Fat and Fermentation Study is researching how different types of dairy products, specifically full-fat and fat-free milk and yogurt, affect gut health and heart disease risk. The study aims to understand how consuming these dairy products may change the balance of microorganisms in your gut and the substances they produce. This information could help improve dietary recommendations for reducing heart disease risk.

To participate in this study, you need to be over 50 years old, a man or a postmenopausal woman, and have a body mass index (BMI) between 25 and 35. You should not have any allergies to milk or follow a diet that excludes dairy. Participants will consume specific dairy products and provide information about their health, and they'll be monitored for any changes in gut health and heart disease risk factors. If you meet the eligibility criteria and are interested, this study could be a valuable opportunity to contribute to important health research.

Gender

ALL

Eligibility criteria

  • 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

About Tufts University

Tufts University is a prestigious research institution renowned for its commitment to advancing health and medicine through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Tufts leverages its expertise in biomedical research, public health, and clinical practice to design and conduct rigorous studies that address critical health challenges. The university's clinical trial programs are characterized by their adherence to high ethical standards and regulatory compliance, ensuring the safety and well-being of participants while contributing valuable insights to the scientific community. Through its dedication to fostering education and research, Tufts University plays a vital role in translating findings into effective health interventions and policies.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Alice H Lichtenstein, D. Sc.

Principal Investigator

Tufts University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported