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| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Whey Breakfast | Experimental | 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 |
|
| Arm 2: No Whey Breakfast | Active Comparator | 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 |
|
| Arm 3: Low Protein Breakfast | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 Whey Breakfast | Other | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | Postprandial plasma glucose after breakfast, lunch and dinner | 12 weeks |
| 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. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Jakubowicz, MD | Hospital de Clinicas Caracas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniela Jakubowicz | Holon | N/A = Not Applicable | 58100 | Israel | ||
| Daniela Jakubowicz |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067796 | Whey |
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Arm 2 No Whey Breakfast | Other | 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) |
|
|
| Arm 3 Low Protein Breakfast | Other | 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) |
|
|
| 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 |
| Caracas |
| San Bernardino |
| 410 |
| Venezuela |
| D004700 | Endocrine System Diseases |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |