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Trial record 26 of 401 for:    PYY

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

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ClinicalTrials.gov Identifier: NCT03772067
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Zohar Landau
Shani Tsameret
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University

Tracking Information
First Submitted Date  ICMJE December 8, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date December 11, 2018
Estimated Study Start Date  ICMJE December 28, 2018
Estimated Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • Continuous Glucose Monitoring (CGM) [ Time Frame: two weeks ]
    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)
  • HbA1c [ Time Frame: 3 months ]
    The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing HbA1c
  • Body Weight [ Time Frame: 3 months ]
    The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing body weight
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D
Official Title  ICMJE Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes
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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Type2 Diabetes
  • Healthy Obesity, Metabolically
Intervention  ICMJE
  • Device: Continuous glucose monitoring 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
    Other Name: CGM
  • Diagnostic Test: Clock Genes m RNA expression
    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
    Other Name: CG
  • Diagnostic Test: Postprandial Glucose
    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
    Other Name: PPG
  • Diagnostic Test: Postprandial 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
    Other Name: Insulin
  • Diagnostic Test: Plasma 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
    Other Name: GLP-1
  • Diagnostic Test: DPP4 plasma activity
    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
    Other Name: DPP4
  • Diagnostic Test: Ghrelin
    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
  • Diagnostic Test: Plasma 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
    Other Name: CCK
  • Diagnostic Test: Plasma 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
    Other Name: PYY
  • Other: Body 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
    Other Name: Weight
  • Diagnostic Test: Blood levels of 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
    Other Name: HbA1c
Study Arms  ICMJE
  • Experimental: MBdiet
    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.
    Interventions:
    • 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
  • Active Comparator: OBdiet
    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.
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 20, 2019
Estimated Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: DANIELA JAKUBOWICZ, MD +972508105552 daniela.jak@gmail.com
Contact: Julio Wainstein, MD +972506296940 vainstein@wolfson.health.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772067
Other Study ID Numbers  ICMJE 0226-17-WOMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniela Jakubowicz, Tel Aviv University
Study Sponsor  ICMJE Tel Aviv University
Collaborators  ICMJE
  • Zohar Landau
  • Shani Tsameret
Investigators  ICMJE Not Provided
PRS Account Tel Aviv University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP