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Milk on Gut Microbiome and Bone Remodeling CTX in Postmenopausal Women

NCT06050018 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-22

No results posted yet for this study

Summary

Milk consumption drives beneficial effect on Bone Mass Density and on Gut Microbiome. Altered Gut Microbiome is associated with postmenopausal status, reduced Bone Mass Density, abnormal serum levels of Bone Turnover Markers (BTM), and disrupted T-cell immune mediation of several proinflammatory cytokines. The investigators hypothesize that a dietary intervention supplemented with milk and other non-fermented dairy products (YesMdiet), compared to an isocaloric diet with equivalent protein and calcium content but non-dairy protein sources (NoMdiet), will lead to favorable changes of Gut Microbiome \[Primary end-point\] in association with improved serum Bone Turnover Markers and serum proinflammatory cytokine profiles.

Conditions

Interventions

OTHER

YesMilkdiet

In the YesMilkdiet the participants will consume Milk and dairy products

OTHER

NoMilkdiet

In the NoMilkdiet the participants will not consume milk or dairy products only another sources of proteins

Sponsors & Collaborators

  • Wolfson Medical Center

    collaborator OTHER_GOV

  • Tel Aviv University

    lead OTHER

Principal Investigators

  • Ornit Cohen · Wolfson Medical Center. Head of the Authority for Research and Innovation.

  • Rachel C Rosenblum, MD · Wolfson Medical Center. Endocrinology and Diabetes Unit

  • Orit Twito, MD · Wolfson Medical Center. Head of Endocrinology and Diabetes Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
48 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-10-31
Completion
2024-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06050018 on ClinicalTrials.gov