Type2 DiabetesMdietNCT03772067
Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D
A study testing Continuous glucose monitoring CGM, Clock Genes m RNA expression and Postprandial Glucose in people with Type2 Diabetes and Healthy Obesity, Metabolically, run by Tel Aviv University at 2 sites in Israel.
Trial summary
This study in T2D patients is undertaken to evaluate the effect of previously studied 3Meals Diet, high energy breakfast (Bdiet) with milk and dairy proteins (MBdiet) versus isocaloric diet with same meal distribution but with other sources of protein (OBdiet) overall postprandial glycemia (PPG), weight loss (WL)… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Healthy Obesity, Metabolically
- What is being tested?
- Continuous glucose monitoring CGM, Clock Genes m RNA expression and Postprandial Glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- 28 Dec 2018to 20 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with T2D < 20 years;
- HgA1c ≥ 7.0 %.
- BMI - 28-40 kg/m2
- Men and women 30 -75 years of age inclusive.
- Normal liver, kidney and thyroid functions, negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2.
- Type 2 diabetes controlled with diet and lifestyle alone or with antidiabetic treatment other than insulin (i.e. buguanides, 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 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 month of the study and should not have crossed time zones within 2 weeks of 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: (estimated glomerular filtration rate 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.
- 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 with 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. No change in medication or nutrition supplements or physical activity will be made during the study. Not able to give informed consent
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Diabetes Unit E. Wolfson Hospital
Holon, Tel Aviv, 58100
Daniela Jakubowicz
Holon, Wolfson Medical Center, 58100
About this study
Official title: Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes
This study in T2D patients is undertaken to evaluate the effect of previously studied 3Meals Diet, high energy breakfast (Bdiet) with milk and dairy proteins (MBdiet) versus isocaloric diet with same meal distribution but with other sources of protein (OBdiet) overall postprandial glycemia (PPG), weight loss (WL), HbA1c, CG expression and on PPG, insulin, C-peptide, GLP-1, gut peptide YY (PYY), cholecystokinin (CCK), ghrelin, dipeptidyl peptidase-4 plasma activity (DPP-4) and appetite responses after high protein breakfast. challenge including milk and dairy products (MBdiet) and after breakfast challenge with same protein content but different source of protein (OBdiet)
Read the detailed description
Increased circadian glucose excursions and overall postprandial glycemia (PPG) are linked to HbA1c and cardiovascular risk in T2D.
Most of the metabolic pathways involved in PPG i.e. secretion of insulin and glucagon-like peptide-1 (GLP-1), are controlled by circadian clock genes (CG). However, the CG regulation is bidirectional, indeed high protein breakfast (B), by increasing insulin and GLP-1 upregulate CG expression leading to reduced overall PPG, HbA1c and weight loss (WL) in T2D. Furthermore in recent study the investigators have shown that in type 2 diabetic patient treated with insulin a diet with 3 Meal Diet consisting in high energy and protein breakfast, medium sized lunch and low energy dinner, with selective time restriction from carbohydrate consumption after 15:00, designed as Bdiet; was more effective approach for reduction of overall PPG, HbA1c and for upregulation of Clock Genes (CG) mRNA expression compared to isocaloric 6 Meal Diet, with calories and macronutrient evenly distributed along the day in three main meals and 3 snack in between.
As the beneficial effects of high energy and protein breakfast in 3Meal diet on the reduction of body weight, overall glycemia and up regulation CG expression, have been demonstrated, in recent studies, we hypothesized that some sources of protein in the breakfast may exert be more beneficial than other source of protein on body weight, PPG, HbA1c and on CG expression Milk consumption is linked to lower risk for obesity and T2D. In acute studies, the addition of milk to carbohydrates in B, displayed greater lowering effect of glucose response after breakfast, lunch and dinner compared with other protein sources.
However the effect of a diet 3Mdiet with high energy and dairy protein breakfast (MBdiet), on overall PPG, weight loss HbA1c, the effect on effect on circadian clock genes and AMPK mRNA expression and on the postprandial glucose, insulin, C-peptide, GLP-1, PYY, CCK, ghrelin, DPP4 plasma activity and appetite has never been explored and never were compared to isocaloric 3Mdiet with other then dairy protein source of protein (OBdiet) in long term study in T2D individuals .
The investigators hypothesize that a diet with high energy and protein breakfast consisting on milk and dairy proteins (MBdiet), by enhancing clock gene expression will lead to more efficient weight loss reduction of overall PPG, and glucose control (HbA1c), compared to a diet with other (non dairy) proteins in the breakfast (OBdiet). The investigators also hypothesize that the dairy breakfast effects in MBdiet may be mediated, at least in part, by integration of events that promote greater postprandial glucose insulin, C-peptide, GLP-1, PYY, and CCK, and greater suppression of ghrelin appetite and DPP4 plasma activity,
- Conditions
- Type2 Diabetes, Healthy Obesity, Metabolically
- Being tested
- Continuous glucose monitoring CGM, Clock Genes m RNA expression, Postprandial Glucose, Postprandial Insulin, Plasma GLP-1
- Medical subject headings
- Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring CGMDevice
Also called CGM
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention
Clock Genes m RNA expressionDiagnostic test
Also called CG
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention
Postprandial GlucoseDiagnostic test
Also called PPG
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention
Postprandial InsulinDiagnostic test
Also called Insulin
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention
Plasma GLP-1Diagnostic test
Also called GLP-1
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention
DPP4 plasma activityDiagnostic test
Also called DPP4
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention
GhrelinDiagnostic test
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention
Plasma CCKDiagnostic test
Also called CCK
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention
Plasma PYYDiagnostic test
Also called PYY
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention
Body WeightOther
Also called Weight
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention
Blood levels of HbA1cDiagnostic test
Also called HbA1c
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention
| Study group | Role | What they receive |
|---|---|---|
| MBdiet | Experimental | This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will contain 38 g protein mostly from milk and dairy products. Receives: Device: Continuous glucose monitoring CGM; Diagnostic Test: Clock Genes m RNA expression; Diagnostic Test: Postprandial Glucose; Diagnostic Test: Postprandial Insulin; Diagnostic Test: Plasma GLP-1; Diagnostic Test: DPP4 plasma activity; Diagnostic Test: Ghrelin; Diagnostic Test: Plasma CCK; Diagnostic Test: Plasma PYY; Other: Body Weight; Diagnostic Test: Blood levels of HbA1c |
| OBdiet | Active comparator | This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will 38 g protein without milk or dairy products mostly from other proteins, i.e. eggs, tuna, soy, oatmeal. Milk product will be avoided in this diet also in other meals along the day. Receives: Device: Continuous glucose monitoring CGM; Diagnostic Test: Clock Genes m RNA expression; Diagnostic Test: Postprandial Glucose; Diagnostic Test: Postprandial Insulin; Diagnostic Test: Plasma GLP-1; Diagnostic Test: DPP4 plasma activity; Diagnostic Test: Ghrelin; Diagnostic Test: Plasma CCK; Diagnostic Test: Plasma PYY; Other: Body Weight; Diagnostic Test: Blood levels of HbA1c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clock genes mRNA expression
The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing the clock genes expression
Measured: two weeks
Secondary outcomes (3)
Continuous Glucose Monitoring (CGM)
The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing overall glycemia assessed by Continuous Glucose Monitoring (CGM)
Measured: two weeks
HbA1c
The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing HbA1c
Measured: 3 months
Body Weight
The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing body weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start28 Dec 2018 (estimated)
- Primary completion20 Jun 2019 (estimated)
- Study completion20 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Zohar Landau, Shani Tsameret
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772067
- Sponsor's protocol ID
- 0226-17-WOMC
- Acronym
- Mdiet
- Status last verified
- Dec 2018
- First submitted
- 8 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsameret S, Froy O, Matz Y, Landau Z, Twito O, Wainstein J, Avital-Cohen N, Chapnik N, Jakubowicz D. Glycaemic, appetite and circadian benefits of a dairy-enriched diet with high-protein breakfast and early daytime-restricted carbohydrate intake in type 2 diabetes: a randomised crossover trial. Diabetologia. 2026 Apr;69(4):1021-1034. doi: 10.1007/s00125-025-06658-2. Epub 2026 Jan 23.
PubMed 41578008
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03772067
- Acronym / sponsor ID
- Mdiet / 0226-17-WOMC
- Conditions
- Type2 Diabetes, Healthy Obesity, Metabolically
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Zohar Landau, Shani Tsameret
- Study start
- 28 Dec 2018 (estimated)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 20 Oct 2019 (estimated)
- First posted
- 11 Dec 2018 (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.
This study in T2D patients is undertaken to evaluate the effect of previously studied 3Meals Diet, high energy breakfast (Bdiet) with milk and dairy proteins (MBdiet) versus isocaloric diet with same meal distribution but with other sources of protein (OBdiet) overall postprandial glycemia (PPG), weight loss (WL), HbA1c, CG expression and on PPG, insulin, C-peptide, GLP-1, gut peptide YY (PYY), cholecystokinin (CCK), ghrelin, dipeptidyl peptidase-4 plasma activity (DPP-4) and appetite responses after high protein breakfast. challenge including milk and dairy products (MBdiet) and after breakfast challenge with same protein content but different source of protein (OBdiet)
Detailed description
Increased circadian glucose excursions and overall postprandial glycemia (PPG) are linked to HbA1c and cardiovascular risk in T2D.
Most of the metabolic pathways involved in PPG i.e. secretion of insulin and glucagon-like peptide-1 (GLP-1), are controlled by circadian clock genes (CG). However, the CG regulation is bidirectional, indeed high protein breakfast (B), by increasing insulin and GLP-1 upregulate CG expression leading to reduced overall PPG, HbA1c and weight loss (WL) in T2D. Furthermore in recent study the investigators have shown that in type 2 diabetic patient treated with insulin a diet with 3 Meal Diet consisting in high energy and protein breakfast, medium sized lunch and low energy dinner, with selective time restriction from carbohydrate consumption after 15:00, designed as Bdiet; was more effective approach for reduction of overall PPG, HbA1c and for upregulation of Clock Genes (CG) mRNA expression compared to isocaloric 6 Meal Diet, with calories and macronutrient evenly distributed along the day in three main meals and 3 snack in between.
As the beneficial effects of high energy and protein breakfast in 3Meal diet on the reduction of body weight, overall glycemia and up regulation CG expression, have been demonstrated, in recent studies, we hypothesized that some sources of protein in the breakfast may exert be more beneficial than other source of protein on body weight, PPG, HbA1c and on CG expression Milk consumption is linked to lower risk for obesity and T2D. In acute studies, the addition of milk to carbohydrates in B, displayed greater lowering effect of glucose response after breakfast, lunch and dinner compared with other protein sources.
However the effect of a diet 3Mdiet with high energy and dairy protein breakfast (MBdiet), on overall PPG, weight loss HbA1c, the effect on effect on circadian clock genes and AMPK mRNA expression and on the postprandial glucose, insulin, C-peptide, GLP-1, PYY, CCK, ghrelin, DPP4 plasma activity and appetite has never been explored and never were compared to isocaloric 3Mdiet with other then dairy protein source of protein (OBdiet) in long term study in T2D individuals .
The investigators hypothesize that a diet with high energy and protein breakfast consisting on milk and dairy proteins (MBdiet), by enhancing clock gene expression will lead to more efficient weight loss reduction of overall PPG, and glucose control (HbA1c), compared to a diet with other (non dairy) proteins in the breakfast (OBdiet). The investigators also hypothesize that the dairy breakfast effects in MBdiet may be mediated, at least in part, by integration of events that promote greater postprandial glucose insulin, C-peptide, GLP-1, PYY, and CCK, and greater suppression of ghrelin appetite and DPP4 plasma activity,
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| MBdiet | Experimental | Device: Continuous glucose monitoring CGM, Diagnostic Test: Clock Genes m RNA expression, Diagnostic Test: Postprandial Glucose, Diagnostic Test: Postprandial Insulin, Diagnostic Test: Plasma GLP-1, Diagnostic Test: DPP4 plasma activity, Diagnostic Test: Ghrelin, Diagnostic Test: Plasma CCK, Diagnostic Test: Plasma PYY, Other: Body Weight, Diagnostic Test: Blood levels of HbA1cThis arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will contain 38 g protein mostly from milk and dairy products. |
| OBdiet | Active comparator | Device: Continuous glucose monitoring CGM, Diagnostic Test: Clock Genes m RNA expression, Diagnostic Test: Postprandial Glucose, Diagnostic Test: Postprandial Insulin, Diagnostic Test: Plasma GLP-1, Diagnostic Test: DPP4 plasma activity, Diagnostic Test: Ghrelin, Diagnostic Test: Plasma CCK, Diagnostic Test: Plasma PYY, Other: Body Weight, Diagnostic Test: Blood levels of HbA1cThis arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will 38 g protein without milk or dairy products mostly from other proteins, i.e. eggs, tuna, soy, oatmeal. Milk product will be avoided in this diet also in other meals along the day. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients diagnosed with T2D < 20 years;
- HgA1c ≥ 7.0 %.
- BMI - 28-40 kg/m2
- Men and women 30 -75 years of age inclusive.
- Normal liver, kidney and thyroid functions, negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2.
Key exclusion criteria (6 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: (estimated glomerular filtration rate 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.
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 |
|---|---|---|
| Continuous glucose monitoring CGMAlso: CGMThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention | Device | MBdiet, OBdiet |
| Clock Genes m RNA expressionAlso: CGThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| Postprandial GlucoseAlso: PPGThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| Postprandial InsulinAlso: InsulinThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| Plasma GLP-1Also: GLP-1The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| DPP4 plasma activityAlso: DPP4The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| GhrelinThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| Plasma CCKAlso: CCKThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| Plasma PYYAlso: PYYThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention | Diagnostic test | MBdiet, OBdiet |
| Body WeightAlso: WeightThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention | Other | MBdiet, OBdiet |
| Blood levels of HbA1cAlso: HbA1cThe effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention | Diagnostic test | MBdiet, OBdiet |
Primary outcome
Clock genes mRNA expression
Time frame: two weeks
The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing the clock genes expression
3 secondary outcomes
Continuous Glucose Monitoring (CGM)
Time frame: two weeks
HbA1c
Time frame: 3 months
Body Weight
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 41578008Tsameret S, Froy O, Matz Y, Landau Z, Twito O, Wainstein J, Avital-Cohen N, Chapnik N, Jakubowicz D. Glycaemic, appetite and circadian benefits of a dairy-enriched diet with high-protein breakfast and early daytime-restricted carbohydrate intake in type 2 diabetes: a randomised crossover trial. Diabetologia. 2026 Apr;69(4):1021-1034. doi: 10.1007/s00125-025-06658-2. Epub 2026 Jan 23.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring CGM, Clock Genes m RNA expression and Postprandial Glucose in people with Type2 Diabetes and Healthy Obesity, Metabolically, run by Tel Aviv University at 2 sites in Israel.
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 10 inclusion and 6 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clock genes mRNA expression (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772067, which also lists 1 linked publication.
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 11 Dec 2018.