COMPLETED

Dairy Fat and Fermentation Study

Conditions

Heart Diseases Microbial Colonization Inflammation gut microbiome gut microbiota yogurt milk heart disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Full-Fat and Fat-Free Dairy, With and Without Fermentation, on Fecal Microbiome, Fecal and Serum Metabolome, and Host Cardiometabolic Risk Status

Quick Facts

Study Start:2023-10-01

Study Completion:2025-08-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05840081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Alice H Lichtenstein, D. Sc.

PRINCIPAL_INVESTIGATOR

Tufts University

Study Locations (Sites)

Jean Mayer Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111

United States

Collaborators and Investigators

Sponsor: Tufts University

Alice H Lichtenstein, D. Sc., PRINCIPAL_INVESTIGATOR, Tufts University

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

Study Start Date2023-10-01

Study Completion Date2025-08-19

Study Record Updates

Study Start Date2023-10-01

Study Completion Date2025-08-19

Terms related to this study

Keywords Provided by Researchers

gut microbiome
gut microbiota
yogurt
milk
heart disease

Additional Relevant MeSH Terms

Heart Diseases
Microbial Colonization
Inflammation