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

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

Interventions

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

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

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

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

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

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

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

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

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

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

Sponsors & Collaborators

• Zohar Landau

  collaborator UNKNOWN

• Shani Tsameret

  collaborator UNKNOWN

• Tel Aviv University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-28

Primary Completion

2019-06-20

Completion

2019-10-20

Countries

• Israel

Study Locations