MenopauseMilk-CTX-GMNCT06050018
Milk on Gut Microbiome and Bone Remodeling CTX in Postmenopausal Women
A study testing YesMilkdiet and NoMilkdiet in people with Menopause, run by Tel Aviv University.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- YesMilkdiet and NoMilkdiet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Milk Consumption on Gut Microbiome and Bone Remodeling Assessed by Serum C-telopeptide (CTX), Osteocalcin (OC) and Parathyroid Hormone (PTH) in Postmenopausal Women
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.
Read the detailed description
Milk consumption is associated with favorable effects on Bone Mass Density, prevention of osteoporosis and beneficial changes in Gut Microbiome. Alteration of Fecal or Gut Microbiome (dysbiosis) is related to disturbances of osteoblastic bone formation and osteoclastic resorption, reduced Bone Mass Density, and abnormal serum levels of Bone Turnover Markers including serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX) or C-terminal telopeptide (CTX).The mechanism behind the deleterious effect of abnormal Gut Microbiome (GM) composition on bone includes effects on gut permeability, reduced production of short chain fatty acids, reduced insulin-like growth factor-1 and disrupted serum levels of T-cell immune mediation of several proinflammatory cytokines, e.g. tumor necrosis factor α (TNFα), transforming growth factor beta (TGF beta) and interleukin-17 (IL-17).
The investigators hypothesize that a dietary intervention (DI) 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 i.e., calcium-fortified soy and tofu or cheese substitutes (NoMdiet), will lead to favorable changes in composition and diversity in fecal samples for GM [Primary end-point] in association with improved serum Bone Turnover Markers namely of serum C-terminal telopeptide (CTX). and in serum levels of proinflammatory cytokine profiles. The effect of the two DI on Gut Microbiome and Bone Turnover Markers will be assessed in a random cross-over design. The cohort will include 15 postmenopausal women. GM and serum Bone Turnover Marker C-terminal telopeptide (CTX), and serum proinflammatory cytokines, will be assessed before and after 4 weeks of each diet intervention, (YesMdiet and NoMdiet), separated by 2 weeks of washout. Gut Microbiome composition and diversity will be assessed in fecal samples using 16S ribosomal RNA (rRNA) gene sequencing and shotgun metagenomics. Serum levels of Bone Turnover Marker C-terminal telopeptide (CTX), and serum levels of proinflammatory cytokines including tumor necrosis factor α (TNFα), transforming growth factor β (TGFβ) and interleukin-17 (IL-17), will be assessed in fasting serum samples.
This study will reveal whether dairy consumption improves the Gut Microbiome profile as well as serum Bone Turnover Marker C-terminal telopeptide (CTX), and proinflammatory cytokines in post-menopausal women, and will help to assess its value of dairy consumption as a potential intervention tool for preserving Bone Density and management of osteoporosis in postmenopausal women.
- Conditions
- Menopause
- Being tested
- YesMilkdiet, NoMilkdiet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YesMilkdietOther
Also called YesMdiet
In the YesMilkdiet the participants will consume Milk and dairy products
NoMilkdietOther
Also called NoMdiet
In the NoMilkdiet the participants will not consume milk or dairy products only another sources of proteins
| Study group | Role | What they receive |
|---|---|---|
| YesMilkdiet | Experimental | After one week baseline, the participants will be assigned to YesMilkdiet consuming milk and dairy products for 4 weeks Receives: 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 Receives: Other: NoMilkdiet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (2)
Serum C-terminal telopeptide (CTX)
Serum Bone Turnover Marker C-terminal telopeptide (CTX) (ng/ml), will be assessed in fasting serum samples collected after 4 weeks of diet intervention
Measured: 4 weeks
Proinflammatory Cytokines
Serum levels of Proinflammatory Cytokines: tumor necrosis factor α (TNFα), transforming growth factor beta (TGF beta) and interleukin-17 (IL-17) will be assessed in fasting serum samples collected after 4 weeks of diet intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Wolfson Medical Center
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Ornit Cohen, Study director, Wolfson Medical Center. Head of the Authority for Research and Innovation.Rachel C Rosenblum, MD, Principal investigator, Wolfson Medical Center. Endocrinology and Diabetes UnitOrit Twito, MD, Study chair, Wolfson Medical Center. Head of Endocrinology and Diabetes Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050018
- Sponsor's protocol ID
- 0203-22 WOMC
- Acronym
- Milk-CTX-GM
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Consumption on Gut Microbiome and Bone Remodeling Assessed by Serum C-telopeptide (CTX), Osteocalcin (OC) and Parathyroid Hormone (PTH) in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06050018
- Acronym / sponsor ID
- Milk-CTX-GM / 0203-22 WOMC
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Wolfson Medical Center
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Milk consumption is associated with favorable effects on Bone Mass Density, prevention of osteoporosis and beneficial changes in Gut Microbiome. Alteration of Fecal or Gut Microbiome (dysbiosis) is related to disturbances of osteoblastic bone formation and osteoclastic resorption, reduced Bone Mass Density, and abnormal serum levels of Bone Turnover Markers including serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX) or C-terminal telopeptide (CTX).The mechanism behind the deleterious effect of abnormal Gut Microbiome (GM) composition on bone includes effects on gut permeability, reduced production of short chain fatty acids, reduced insulin-like growth factor-1 and disrupted serum levels of T-cell immune mediation of several proinflammatory cytokines, e.g. tumor necrosis factor α (TNFα), transforming growth factor beta (TGF beta) and interleukin-17 (IL-17).
The investigators hypothesize that a dietary intervention (DI) 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 i.e., calcium-fortified soy and tofu or cheese substitutes (NoMdiet), will lead to favorable changes in composition and diversity in fecal samples for GM [Primary end-point] in association with improved serum Bone Turnover Markers namely of serum C-terminal telopeptide (CTX). and in serum levels of proinflammatory cytokine profiles. The effect of the two DI on Gut Microbiome and Bone Turnover Markers will be assessed in a random cross-over design. The cohort will include 15 postmenopausal women. GM and serum Bone Turnover Marker C-terminal telopeptide (CTX), and serum proinflammatory cytokines, will be assessed before and after 4 weeks of each diet intervention, (YesMdiet and NoMdiet), separated by 2 weeks of washout. Gut Microbiome composition and diversity will be assessed in fecal samples using 16S ribosomal RNA (rRNA) gene sequencing and shotgun metagenomics. Serum levels of Bone Turnover Marker C-terminal telopeptide (CTX), and serum levels of proinflammatory cytokines including tumor necrosis factor α (TNFα), transforming growth factor β (TGFβ) and interleukin-17 (IL-17), will be assessed in fasting serum samples.
This study will reveal whether dairy consumption improves the Gut Microbiome profile as well as serum Bone Turnover Marker C-terminal telopeptide (CTX), and proinflammatory cytokines in post-menopausal women, and will help to assess its value of dairy consumption as a potential intervention tool for preserving Bone Density and management of osteoporosis in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| YesMilkdiet | Experimental | Other: YesMilkdietAfter one week baseline, the participants will be assigned to YesMilkdiet consuming milk and dairy products for 4 weeks |
| NoMilkdiet | Active comparator | Other: NoMilkdietAfter one week baseline, the participants will be assigned to NoMilkdiet consuming another source of protein and without milk or dairy products for 4 weeks |
Who may qualify
- Ages
- 48 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Diabetes,
- Prior osteoporotic fracture
- eGFR <60ml/min.
- Vitamin D 25-OH deficiency <10 ng/ml.
- Hypercalcemia Ca > 11.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YesMilkdietAlso: YesMdietIn the YesMilkdiet the participants will consume Milk and dairy products | Other | YesMilkdiet |
| NoMilkdietAlso: NoMdietIn the NoMilkdiet the participants will not consume milk or dairy products only another sources of proteins | Other | NoMilkdiet |
Primary outcome
Gut Microbiome Profile
Time frame: 4 weeks
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
2 secondary outcomes
Serum C-terminal telopeptide (CTX)
Time frame: 4 weeks
Proinflammatory Cytokines
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ornit Cohen study director
Wolfson Medical Center. Head of the Authority for Research and Innovation.
Rachel C Rosenblum, MD principal investigator
Wolfson Medical Center. Endocrinology and Diabetes Unit
Orit Twito, MD study chair
Wolfson Medical Center. Head of Endocrinology and Diabetes Unit
Questions about this trial
What is this clinical trial studying?
A study testing YesMilkdiet and NoMilkdiet in people with Menopause, run by Tel Aviv University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Jakubowicz, MD (972508105552, daniela.jak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Profile (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.