Milk on Gut Microbiome and Bone Remodeling CTX in Postmenopausal Women

NCT06050018 | Unknown

• 1 other identifier: 0203-22 WOMC
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Menopause

Outcome Measures

Primary Outcomes (1)

• Gut Microbiome Profile

  Gut Microbiome composition and diversity will be assessed using 16 rRNA sequencing and Shotgun metagenomics in fecal samples collected in Shield Fecal Tubes, after 4 weeks of diet intervention

  4 weeks

Secondary Outcomes (2)

• Serum C-terminal telopeptide (CTX)

  4 weeks

• Proinflammatory Cytokines

  4 weeks

Study Arms (2)

YesMilkdiet

EXPERIMENTAL

After one week baseline, the participants will be assigned to YesMilkdiet consuming milk and dairy products for 4 weeks

Other: YesMilkdiet

NoMilkdiet

ACTIVE COMPARATOR

After one week baseline, the participants will be assigned to NoMilkdiet consuming another source of protein and without milk or dairy products for 4 weeks

Other: NoMilkdiet

Interventions

YesMilkdiet OTHER

In the YesMilkdiet the participants will consume Milk and dairy products

Also known as: YesMdiet

YesMilkdiet

NoMilkdiet OTHER

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

Also known as: NoMdiet

NoMilkdiet

Eligibility Criteria

• Age: 48 Years - 70 Years
• Gender Eligibility Details: Only menopausal women will be recruited
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal status, defined by ≥ 1 year since last menstrual period and/or serum FSH ≥ 30 IU/l
• Normal liver, thyroid, parathyroid and kidney function eGFR \> 60ml/min
• Usual Milk and milk products consumption

You may not qualify if:

• Diabetes,
• Prior osteoporotic fracture
• eGFR \<60ml/min.
• Vitamin D 25-OH deficiency \<10 ng/ml.
• Hypercalcemia Ca \> 11.
• Chronic gastrointestinal disease, or acute condition with nausea, vomiting or diarrhea in the past month.
• Bariatric Surgery.
• Known hypersensitivity to milk components or lactose intolerance.
• Vegan/vegetarian
• Treatment with antibiotics or ingestion of prebiotics or probiotics in the 3 months preceding the study.
• Use of anti-osteoporosis medicines (e.g., bisphosphonates, raloxifene, calcitonin, teriparatide, and denosumab) within 36 months before enrollment.
• Use of Hormone replacement therapy, Vitamin K antagonists (e.g., warfarin), heparin, thiazide diuretics, anticonvulsants, aromatase inhibitors.
• Illicit drug abuse or alcoholism within one year prior to study onset;
• Use of glucocorticoids within 3 months prior to study onset.

Sponsors & Collaborators

• Tel Aviv University: lead
• Wolfson Medical Center: collaborator

Study Officials

• Ornit Cohen

  Wolfson Medical Center. Head of the Authority for Research and Innovation.

  STUDY DIRECTOR

• Rachel C Rosenblum, MD

  Wolfson Medical Center. Endocrinology and Diabetes Unit

  PRINCIPAL INVESTIGATOR

• Orit Twito, MD

  Wolfson Medical Center. Head of Endocrinology and Diabetes Unit

  STUDY CHAIR

Central Study Contacts

Daniela Jakubowicz, MD

CONTACT

972508105552; daniela.jak@gmail.com

Rachel C Rosenblum, MD

CONTACT

972524787673; Rachrose613@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Daniela Jakubowicz MD

Model Details: In a crossover design the effect of Yes Milk Diet (YesMdiet) and of No Milk Diet (NoMdiet) on Gut Microbiome (GM) and Bone Turnover Markers will be assessed in the participants in random order

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 22, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09