High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D

Study Overview
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Brief Summary
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The investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals

Detailed Description
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Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie and protein breakfast promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression. However the effect of isocaloric and isoproteic breakfast with different source of proteins, (whey vs other proteins or vs low protein in breakfast) on weight loss, appetite and on glycemic fluctuations after breakfast lunch and dinner was not explored in obese diabetic individuals. To search whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast will lead to reduced hunger and overall postprandial glycemia and will enhance weight loss in obese diabetic individuals

Official Title
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Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Arm 1 Whey Breakfast
* Other: Arm 2 No Whey Breakfast
* Other: Arm 3 Low Protein Breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥30 and ≤70 years of age BMI: 26 to 34 kg/m2) Diabetes criteria HbA1C: 7-9 % or Habitually eat breakfast Only naïve or treated with metformin. Those with anti-hypertensive and lipid-lowering medication will be included. . Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months 10.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation. 12. Normal liver, kidney and thyroid function. 13. Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) > 60 mL/min/1.73 m2. Exclusion Criteria: Type 1 Diabetes Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease Anemia (Hg > 10 g/dL) Serum creatinine level < 1.5 mg/dl Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate Infectious disease Malignancy Pregnant women or lactating Known hypersensitivity to milk components 10. Participating in dietary program or using of weight-loss medications 11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism. 12. Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset -

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Whey Breakfast<br>The arm 1 will be assigned to eating Whey protein in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein namely from whey at breakfast | Other: Arm 1 Whey Breakfast<br>* The patients will be assigned to eat 42 g protein namely from Whey protein in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)<br>* Other names: Whey;|
| Active Comparator: Arm 2: No Whey Breakfast<br>The arm 2 will be assigned to intake other proteins (No Whey) in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein from other sources at breakfast | Other: Arm 2 No Whey Breakfast<br>* The patients will be assigned to eat 42 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)<br>* Other names: No Whey;|
| Placebo Comparator: Arm 3: Low Protein Breakfast<br>The arm 3 will be assigned to intake low protein and high carbohydrate breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 22 g protein from other sources at breakfast | Other: Arm 3 Low Protein Breakfast<br>* The patients will be assigned to eat 22 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)<br>* Other names: Low Protein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose | Postprandial plasma glucose after breakfast, lunch and dinner | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Insulin | Postprandial plasma insulin after breakfast lunch and dinner | 12 weeks | 
| Hunger | Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale. | 12 weeks | 
| Satiety | Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale. | 12 weeks | 
| Change in body weight | Body weight will be assessed every every two weeks until week 12 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whey protein, hunger