Milk Consumption and Blood Microbiome in Healthy Volunteers

NCT06944002 | Recruiting

• 2 other identifiers: NL88008.078.24KICH2.V4P.22.015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if cfDNA of milk-associated intestinal bacteria (MAIB) is detectable in the bloodstream. The primary question it aims to answer is: \- Does milk consumption simultaneously increase the number of MAIB cfDNA counts in blood samples, as it does in fecal samples? Researchers will compare cfDNA counts of MAIB to those of fecal samples to assess whether the blood microbiome is a valid measure of the gut microbiome, utilizing a self-developed bioinformatics pipeline. Participants will:

• Abstain from consuming any dairy products for ten days, followed by drinking milk for 7 consecutive days.
• Provide blood and fecal samples before dairy abstinence, as well as at 0, 24, and 48 hours, and one week after the reintroduction of milk.

Conditions

Healthy

Keywords

The blood microbiome; The gut microbiome; Milk consumption; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Changes in Lactococcus DNA counts

  Changes in blood and fecal Lactococcus DNA during milk consumption will be measured with shotgun sequencing technology.

  10 days before milk consmuption (baseline), 0, 1, 2 and 7 days during milk consumption

Secondary Outcomes (1)

• Changes in other microbial DNA counts

  10 days before milk consmuption, 0, 1, 2 and 7 days during milk consumption

Other Outcomes (2)

• Change in BMI

  10 days before milk consmuption, 0, 1, 2 and 7 days during milk consumption

• Change in systolic and diastolic blood pressure

  10 days before milk consmuption, 0, 1, 2 and 7 days during milk consumption

Study Arms (1)

Milk consumption

EXPERIMENTAL

Milk consumption for 7 days

Dietary Supplement: Milk product

Interventions

Milk product DIETARY_SUPPLEMENT

The participants will abstain from consumption of any dairy product for ten days and subsequently drink milk for seven consecutive days (700 ml per day), while concomitant consumption of other dairy products is also allowed.

Milk consumption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• =\< BMI \< 25 kg/m2
• All genders included
• Not be lactose intolerant
• Willing to consume milk

You may not qualify if:

• Regularly used medications such as antibiotics, steroids, beta blockers, and adrenergic- stimulating agents (self-report)
• Regular use of prebiotic and/or probiotics apart from yogurt and young soft cheese (self-report)
• Antibiotic intake in the previous months (self-report)
• Daily consumption of more than 10 cigarettes (self-report)
• Chronic diseases including type 2 diabetes, hypertension, fatty liver disease, cancer, or autoimmune disease (self-report)
• Internal diseases, including those of the gastrointestinal tract, lung, heart, vasculature, liver, and kidney (self-report)
• Eating disorder or unconventional eating habits (self-report)
• Participation in another study (self-report)
• Women: pregnancy and breastfeeding (self-report)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• NWO (Dutch Organisation for Scientific Research): collaborator

Study Sites (1)

Erasmus MC - Department of Gastroenterology and Hepatology

Rotterdam, 3015 GD, Netherlands

RECRUITING

Related Publications (1)

• Su J, Hansen BE, Wang Z, Sharmenov A, Xia X, Broekhuizen M, Ma Z, Peppelenbosch MP. Yogurt reintroduction and the circulating microbiome in healthy volunteers: protocol for a prospective, longitudinal, species-controlled crossover clinical trial (MAMI). Contemp Clin Trials Commun. 2025 Nov 24;48:101579. doi: 10.1016/j.conctc.2025.101579. eCollection 2025 Dec.

  PMID: 41399631 DERIVED

MeSH Terms

Interventions

Cultured Milk Products

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Prof. Dr. Maikel P Peppelenbosch, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

Central Study Contacts

Prof. Dr. Maikel P. Peppelenbosch, MD, PhD

CONTACT

+31 07032792; m.peppelenbosch@erasmusmc.nl

Junhong Su, PhD

CONTACT

j.su.1@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 25, 2025
• Study Start: July 10, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from appearance of the study on the preprint server to at least January 20, 2035
• Access Criteria: the anomised data will be available to everyone

Locations

NL (1)