Type2DiabetesMilk-GMNCT05294861
Effect of Milk Consumption on Glycemia and Gut Microbiome in T2D
A study testing YesMdiet and NoMdiet in people with Type2Diabetes, run by Tel Aviv University.
Trial summary
The overall glycemic excursions display circadian variations which are controlled by the circadian clock genes (CCG) and are strongly influenced by meal timing. Indeed, in T2D, a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type2Diabetes
- What is being tested?
- YesMdiet and NoMdiet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2022to 28 Dec 2022
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with T2D < 20 years
- HbA1c ≥ 6.5 %.
- BMI - 28-45 kg/m2
- Men and women 30 -75 years of age inclusive
- Normal liver, kidney, and thyroid functions, and eGFR > 45 mL/min/1.73 m2.
- Type 2 diabetes controlled with diet, lifestyle alone, or with antidiabetics other than insulin (i.e. biguanides, sulfonylureas, glinides, SGLT2 inhibitors, DPP4 inhibitors, GLP-1 analogs), with stable doses for at least 3 months before entering the study.
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- Stable weight (less than 5% change in body weight in last 3 months before the study - determined by self-reporting or documentation in clinical records).
- Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs will be allowed also on a stable dose for at least 3 months before the beginning of the trial.
- Patients that usually wake up between 06:00 and 08:00 and go to sleep between 22:00 and 24:00.
- Should not have shift work within 6 months of the study and should not have crossed time zones within 2 weeks of the study.
- No change in medication or nutrition supplements or physical activity will be made during the study.
Who cannot join
- Type 1 diabetes or secondary forms of diabetes.
- Patients with latent autoimmune diabetes in adults (LADA).
- Treatment with insulin.
- Serum creatinine level >2mg/dl. Renal dysfunction: eGFR < 45 mL/min/1.73 m2).
- Hepatic dysfunction: liver disease or transaminase levels > 2.5-fold above normal.
- Major illness with life expectancy < 5 years.
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- Malignant neoplasm requiring chemotherapy, surgery, radiation, or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer).
- Those taking psychotropic, anorectic medication, steroid treatment, or illicit drug abuse or alcoholism within one year prior to study onset. Pregnancy or lactation.
- Known hypersensitivity to milk components or lactose intolerance.
- Night or rotating shift workers or those who crossed more than 2 time zones during the 2- week period prior to study onset.
- Not able to give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Milk Consumption on Glycemic Control and Gut Microbiome in Type 2 Diabetes
The overall glycemic excursions display circadian variations which are controlled by the circadian clock genes (CCG) and are strongly influenced by meal timing.
Indeed, in T2D, a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and of overall glycemia versus reverse schedule or six meals, with energy and carbohydrates (CH) evenly distributed throughout the day.
Read more
in addition to meal timing of Bdiet, the source of protein i.e., Milk and dairy products, by favorable changes in the Guts Microbiome (GM) composition may also play a role in the reduction of overall glycemia of T2D.
The investigators hypothesize that Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), will reduce overall glycemia in T2D, compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet).
Study Design: The effect of the two Bdiet interventions on GM will be assessed in T2D participants in a cross-over design, at baseline and after YesMdiet and after NoMdiet, in random order. We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.
Read the detailed description
Background: Reduction of the overall glycemic excursion is the main target in the treatment of T2D to reduce HbA1c and cardiovascular risk. The overall glycemic excursions display circadian variations controlled by the circadian clock genes (CG) and are strongly influenced by meal timing.
Indeed, the investigators have recently shown in T2D, that a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and substantial reduction of overall (diurnal and nocturnal) glycemia as compared to the reverse schedule or a diet with six meals, with energy and carbohydrates (CH) evenly distributed throughout the day.
However, in addition to meal timing, the source of protein in Bdiet and the changes of Gut Microbiome (GM) composition, may also play a role in the reduction of overall glycemia. It has been recently shown that consumption of milk and dairy products is associated beneficial effect on overall glycemia. Further, milk and dairy may exert a beneficial effect on overall glycemia by favorable changes in GM composition.
Working hypothesis: Therefore, in this study, we hypothesize that a Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet) and may lead to favorable changes in the Gut Microbiota (GM) [Primary end-point] in association with the improvement of overall glycemia in T2D participant under continuous glucose monitoring (CGM) surveillance.
Study Design: The effect of the two Bdiet interventions on GM will be assessed in n=16 participants in a cross-over design, at baseline and after 14 days of Bdiet consuming Milk and dairy products (YesMdiet) or isocaloric Bdiet without milk or dairy products (NoMdiet), in random order in T2D individual undergoing CGM surveillance.
Expected results: We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.
Scientific Significance: This trial will reveal whether the benefits of Bdiet on glycemic control is further enhanced by milk and dairy consumption, in association with favorable changes in Gut Microbiome
- Conditions
- Type2Diabetes
- Being tested
- YesMdiet, NoMdiet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YesMdietOther
Also called Yes Milk diet
In the YesMdiet, participants will consume Milk and Dairy products
NoMdietOther
Also called No Milk diet
In the YesMdiet, participants will not consume Milk and Dairy products, only other sources of protein
| Study group | Role | What they receive |
|---|---|---|
| YesMdiet | Experimental | After one week baseline, the participants will be assigned to YesMdiet, consuming milk and dairy products for 14 days Receives: Other: YesMdiet |
| NoMdiet | Active comparator | After one week baseline, the participants will be assigned to NoMdiet, consuming another source of protein and without milk or dairy products for 14 days Receives: Other: NoMdiet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome
Gut Microbiome composition will be assessed using 16s rRNA sequencing method after 14 days of YesMdiet
Measured: 14 day
Secondary outcomes (2)
Gut Microbiome
Gut Microbiome composition will be assessed using 16s rRNA sequencing method after 14 days of NoMdiet
Measured: 14 days
Overall Glycemia
Overall Glycemia will be assessed using continuous glucose monitoring CGM during 14 days of either YesMdiet or NoBdiet
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start28 Apr 2022 (estimated)
- Primary completion28 Oct 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2DiabetesStudies 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 effects of YesMdiet and of NoMdiet on overall glycemia and Gut Microbiome will be assessed in the participants in random order
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294861
- Sponsor's protocol ID
- 0041-22-WOMC
- Acronym
- Milk-GM
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Consumption on Glycemic Control and Gut Microbiome in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05294861
- Acronym / sponsor ID
- Milk-GM / 0041-22-WOMC
- Conditions
- Type2Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 28 Apr 2022 (estimated)
- Primary completion
- 28 Oct 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 24 Mar 2022 (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.
The overall glycemic excursions display circadian variations which are controlled by the circadian clock genes (CCG) and are strongly influenced by meal timing.
Indeed, in T2D, a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and of overall glycemia versus reverse schedule or six meals, with energy and carbohydrates (CH) evenly distributed throughout the day.
in addition to meal timing of Bdiet, the source of protein i.e., Milk and dairy products, by favorable changes in the Guts Microbiome (GM) composition may also play a role in the reduction of overall glycemia of T2D.
The investigators hypothesize that Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), will reduce overall glycemia in T2D, compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet).
Study Design: The effect of the two Bdiet interventions on GM will be assessed in T2D participants in a cross-over design, at baseline and after YesMdiet and after NoMdiet, in random order. We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.
Detailed description
Background: Reduction of the overall glycemic excursion is the main target in the treatment of T2D to reduce HbA1c and cardiovascular risk. The overall glycemic excursions display circadian variations controlled by the circadian clock genes (CG) and are strongly influenced by meal timing.
Indeed, the investigators have recently shown in T2D, that a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and substantial reduction of overall (diurnal and nocturnal) glycemia as compared to the reverse schedule or a diet with six meals, with energy and carbohydrates (CH) evenly distributed throughout the day.
However, in addition to meal timing, the source of protein in Bdiet and the changes of Gut Microbiome (GM) composition, may also play a role in the reduction of overall glycemia. It has been recently shown that consumption of milk and dairy products is associated beneficial effect on overall glycemia. Further, milk and dairy may exert a beneficial effect on overall glycemia by favorable changes in GM composition.
Working hypothesis: Therefore, in this study, we hypothesize that a Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet) and may lead to favorable changes in the Gut Microbiota (GM) [Primary end-point] in association with the improvement of overall glycemia in T2D participant under continuous glucose monitoring (CGM) surveillance.
Study Design: The effect of the two Bdiet interventions on GM will be assessed in n=16 participants in a cross-over design, at baseline and after 14 days of Bdiet consuming Milk and dairy products (YesMdiet) or isocaloric Bdiet without milk or dairy products (NoMdiet), in random order in T2D individual undergoing CGM surveillance.
Expected results: We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.
Scientific Significance: This trial will reveal whether the benefits of Bdiet on glycemic control is further enhanced by milk and dairy consumption, in association with favorable changes in Gut Microbiome
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 effects of YesMdiet and of NoMdiet on overall glycemia and Gut Microbiome will be assessed in the participants in random order
| Arm | Type | Receives |
|---|---|---|
| YesMdiet | Experimental | Other: YesMdietAfter one week baseline, the participants will be assigned to YesMdiet, consuming milk and dairy products for 14 days |
| NoMdiet | Active comparator | Other: NoMdietAfter one week baseline, the participants will be assigned to NoMdiet, consuming another source of protein and without milk or dairy products for 14 days |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients diagnosed with T2D < 20 years
- HbA1c ≥ 6.5 %.
- BMI - 28-45 kg/m2
- Men and women 30 -75 years of age inclusive
- Normal liver, kidney, and thyroid functions, and eGFR > 45 mL/min/1.73 m2.
Key exclusion criteria (11 listed)
- Type 1 diabetes or secondary forms of diabetes.
- Patients with latent autoimmune diabetes in adults (LADA).
- Treatment with insulin.
- Serum creatinine level >2mg/dl. Renal dysfunction: eGFR < 45 mL/min/1.73 m2).
- Hepatic dysfunction: liver disease or transaminase levels > 2.5-fold above normal.
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 |
|---|---|---|
| YesMdietAlso: Yes Milk dietIn the YesMdiet, participants will consume Milk and Dairy products | Other | YesMdiet |
| NoMdietAlso: No Milk dietIn the YesMdiet, participants will not consume Milk and Dairy products, only other sources of protein | Other | NoMdiet |
Primary outcome
Gut Microbiome
Time frame: 14 day
Gut Microbiome composition will be assessed using 16s rRNA sequencing method after 14 days of YesMdiet
2 secondary outcomes
Gut Microbiome
Time frame: 14 days
Overall Glycemia
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Daniela Jakubowicz, MD principal investigator
Wolfson Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing YesMdiet and NoMdiet in people with Type2Diabetes, 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 11 inclusion and 11 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 24 Mar 2022. 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 Julio Wainstein, MD (972-506296940, julio_w@walla.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome (time frame: 14 day). 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 24 Mar 2022.