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Dairy Fat and Fermentation Study

Primary Purpose

Heart Diseases, Microbial Colonization, Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Milk or yogurt beverage
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring gut microbiome, gut microbiota, yogurt, milk, heart disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age >50 years Men and postmenopausal women BMI >25 and <35 kg/m2 No milk allergy, lactose intolerance or adherence to vegan or other dietary pattern that excludes dairy products Non-smoker Usual pattern of bowel movements at least every other day. Exclusion Criteria: Women and men <50 years Women, pre- or peri-menopausal BMI <25 and >35 kg/m2 Current smokers or former smoker who quit < 6 months Use of nicotine replacement products within last 6 months Replacement or gender affirming hormonal therapy use Weight gain of >15 pounds within last 6 months Infrequent bowel movements History of anemia within past 2 years or confirmation of anemia at first study visit Blood donation within last 2 months Untreated hypertension Oral antibiotics use within 2 weeks of study entry Steroid use (including dental prophylaxis use within 2 wks prior to or during study, except non-prescription topical and nasal steroids, e. g. Flonase) Use of lipid lowering medications Chronic use of aspirin, non-steroidal anti-inflammatory medications (NSAIDS), laxatives, anti-diarrheal medication Regular use (>2 times per week) of acid lowering medication: antacids, proton pump inhibitors, or H2 Blockers. Use of dietary supplements other than multi-vitamins, including pre- and probiotics, within 2 months of study entry Milk allergy, lactose intolerance or adherence to vegan or other dietary patterns that exclude dairy products Colonoscopy within 3 weeks of study entry or during study period 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 Chronic heart, liver, thyroid, renal or kidney disease Type I or type II diabetes 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 Participation in other dietary intervention research study during the same time No social security number Not willing to commit to adhering to the protocol

Sites / Locations

  • Jean Mayer Human Nutrition Research Center on Aging

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Full-fat milk beverage

Fat-free milk beverage

Full-fat yogurt beverage

Fat-free yogurt beverage

Arm Description

Beverage made with full-fat milk

Beverage made with fat-free milk

Beverage made with full-fat yogurt

Beverage made with fat-free yogurt

Outcomes

Primary Outcome Measures

gut microbiome
Determine the effects of dairy fat in milk, with and without fermentation, on gut microbiome
fecal metabolome
Determine the effects of dairy fat in milk, with and without fermentation, on fecal metabolome
serum metabolome
Determine the effects of dairy fat in milk, with and without fermentation, on serum metabolome

Secondary Outcome Measures

Full Information

First Posted
April 21, 2023
Last Updated
April 21, 2023
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT05840081
Brief Title
Dairy Fat and Fermentation Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Microbial Colonization, Inflammation
Keywords
gut microbiome, gut microbiota, yogurt, milk, heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized crossover design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full-fat milk beverage
Arm Type
Experimental
Arm Description
Beverage made with full-fat milk
Arm Title
Fat-free milk beverage
Arm Type
Experimental
Arm Description
Beverage made with fat-free milk
Arm Title
Full-fat yogurt beverage
Arm Type
Experimental
Arm Description
Beverage made with full-fat yogurt
Arm Title
Fat-free yogurt beverage
Arm Type
Experimental
Arm Description
Beverage made with fat-free yogurt
Intervention Type
Other
Intervention Name(s)
Milk or yogurt beverage
Intervention Description
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.
Primary Outcome Measure Information:
Title
gut microbiome
Description
Determine the effects of dairy fat in milk, with and without fermentation, on gut microbiome
Time Frame
3 weeks
Title
fecal metabolome
Description
Determine the effects of dairy fat in milk, with and without fermentation, on fecal metabolome
Time Frame
3 weeks
Title
serum metabolome
Description
Determine the effects of dairy fat in milk, with and without fermentation, on serum metabolome
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age >50 years Men and postmenopausal women BMI >25 and <35 kg/m2 No milk allergy, lactose intolerance or adherence to vegan or other dietary pattern that excludes dairy products Non-smoker Usual pattern of bowel movements at least every other day. Exclusion Criteria: Women and men <50 years Women, pre- or peri-menopausal BMI <25 and >35 kg/m2 Current smokers or former smoker who quit < 6 months Use of nicotine replacement products within last 6 months Replacement or gender affirming hormonal therapy use Weight gain of >15 pounds within last 6 months Infrequent bowel movements History of anemia within past 2 years or confirmation of anemia at first study visit Blood donation within last 2 months Untreated hypertension Oral antibiotics use within 2 weeks of study entry Steroid use (including dental prophylaxis use within 2 wks prior to or during study, except non-prescription topical and nasal steroids, e. g. Flonase) Use of lipid lowering medications Chronic use of aspirin, non-steroidal anti-inflammatory medications (NSAIDS), laxatives, anti-diarrheal medication Regular use (>2 times per week) of acid lowering medication: antacids, proton pump inhibitors, or H2 Blockers. Use of dietary supplements other than multi-vitamins, including pre- and probiotics, within 2 months of study entry Milk allergy, lactose intolerance or adherence to vegan or other dietary patterns that exclude dairy products Colonoscopy within 3 weeks of study entry or during study period 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 Chronic heart, liver, thyroid, renal or kidney disease Type I or type II diabetes 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 Participation in other dietary intervention research study during the same time No social security number Not willing to commit to adhering to the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice H Lichtenstein, D. Sc.
Phone
(617) 556-3127
Email
alice.lichtenstein@tufts.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Galluccio, BS
Phone
(617) 556-3121
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice H Lichtenstein, D. Sc.
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer Human Nutrition Research Center on Aging
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volunteer Services
Phone
800-738-7555
Email
volunteers-hnrc@tufts.edu

12. IPD Sharing Statement

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Dairy Fat and Fermentation Study

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