Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D

NCT03772067 | Unknown

• 1 other identifier: 0226-17-WOMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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), 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)

Conditions

Type2 Diabetes; Healthy Obesity, Metabolically

Outcome Measures

Primary Outcomes (1)

• 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

  two weeks

Secondary Outcomes (3)

• Continuous Glucose Monitoring (CGM)

  two weeks

• HbA1c

  3 months

• Body Weight

  3 months

Study Arms (2)

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.

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.

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

Interventions

Continuous glucose monitoring CGM DEVICE

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

Also known as: CGM

MBdiet; OBdiet

Clock Genes m RNA expression DIAGNOSTIC_TEST

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

Also known as: CG

MBdiet; OBdiet

Postprandial Glucose DIAGNOSTIC_TEST

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

Also known as: PPG

MBdiet; OBdiet

Postprandial Insulin DIAGNOSTIC_TEST

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

Also known as: Insulin

MBdiet; OBdiet

Plasma GLP-1 DIAGNOSTIC_TEST

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

Also known as: GLP-1

MBdiet; OBdiet

DPP4 plasma activity DIAGNOSTIC_TEST

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

Also known as: DPP4

MBdiet; OBdiet

Ghrelin DIAGNOSTIC_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

MBdiet; OBdiet

Plasma CCK DIAGNOSTIC_TEST

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

Also known as: CCK

MBdiet; OBdiet

Plasma PYY DIAGNOSTIC_TEST

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

Also known as: PYY

MBdiet; OBdiet

Body Weight OTHER

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

Also known as: Weight

MBdiet; OBdiet

Blood levels of HbA1c DIAGNOSTIC_TEST

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

Also known as: HbA1c

MBdiet; OBdiet

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Aviv University: lead
• Zohar Landau: collaborator
• Shani Tsameret: collaborator

Study Sites (2)

Diabetes Unit E. Wolfson Hospital

Holon, Tel Aviv, 58100, Israel

Location

Daniela Jakubowicz

Holon, Wolfson Medical Center, 58100, Israel

Location

Related Publications (1)

• 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 Jan 23. doi: 10.1007/s00125-025-06658-2. Online ahead of print.

  PMID: 41578008 DERIVED

MeSH Terms

Conditions

Obesity, Metabolically Benign

Interventions

Continuous Glucose Monitoring; Insulin Secretion; Weights and Measures

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Metabolism; Physiological Phenomena

Central Study Contacts

DANIELA JAKUBOWICZ, MD

CONTACT

+972508105552; daniela.jak@gmail.com

Julio Wainstein, MD

CONTACT

+972506296940; vainstein@wolfson.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: December 11, 2018
• Study Start: December 28, 2018
• Primary Completion: June 20, 2019
• Study Completion: October 20, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

IL (2)