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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05840081
Other study ID # 3070
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date December 2026

Study information

Verified date December 2023
Source Tufts University
Contact Alice H Lichtenstein, D. Sc.
Phone (617) 556-3127
Email alice.lichtenstein@tufts.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

A randomized-controlled cross-over trial will be conducted to compare the effect of two servings per day of full-fat and fat-free milk, and full-fat and fat-free yogurt (hence forth referred to as dairy food items) on the gut microbiome, fecal and serum metabolome, and determine their relation to cardiometabolic risk factors (CMRF) and functional pathways associated with the differences identified. Participants will be provided with 2 servings per day of the test dairy products and requested not to consume additional bovine (cow) milk or yogurt during each 3-week diet phase.They will be allowed to use dairy substitutes such as plant-based milk alternatives and consume other types of dairy products (e.g. cheese). The study consists of four diet phases: fat-free milk phase, full-fat milk phase, fat-free yogurt phase and full-fat yogurt phase. Each diet phase is 3 weeks in duration, separated by a 2 week break. Participants will be provided with 2 servings of a dairy based food item per day specific to their assigned phase and asked to consume them at two separate times during the day - morning and evening. Weight, waist circumference and blood pressure will be measured, blood and stool samples will be collected, and participants will complete two 24-hr food recall questionnaires during each phase.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Other:
Milk or yogurt beverage
Commercially available milk or yogurt (depending on experimental arm) will be incorporated into flavored drinks/smoothies to minimize perceived differences among these items, preserving the double-blind nature of the study design.

Locations

Country Name City State
United States Jean Mayer Human Nutrition Research Center on Aging Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary gut microbiome Determine the effects of dairy fat in milk, with and without fermentation, on gut microbiome 3 weeks
Primary fecal metabolome Determine the effects of dairy fat in milk, with and without fermentation, on fecal metabolome 3 weeks
Primary serum metabolome Determine the effects of dairy fat in milk, with and without fermentation, on serum metabolome 3 weeks
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