Type 2 Diabetes
Conditions
Keywords
whey protein, hunger
Brief summary
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
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
Interventions
OTHERArm 1 Whey Breakfast
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)
OTHERArm 2 No Whey Breakfast
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)
OTHERArm 3 Low Protein Breakfast
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)
Sponsors
Tel Aviv University
Hospital de Clinicas Caracas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects ≥30 and ≤70 years of age 2. BMI: 26 to 34 kg/m2) 3. Diabetes criteria 4. HbA1C: 7-9 % or 5. Habitually eat breakfast 6. Only naïve or treated with metformin. 7. Those with anti-hypertensive and lipid-lowering medication will be included. 8. . 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
1. Type 1 Diabetes 2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease 3. Anemia (Hg \> 10 g/dL) 4. Serum creatinine level \< 1.5 mg/dl 5. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery. 6. 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 7. Infectious disease 8. Malignancy 9. Pregnant women or lactating 10. 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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose | 12 weeks | Postprandial plasma glucose after breakfast, lunch and dinner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Insulin | 12 weeks | Postprandial plasma insulin after breakfast lunch and dinner |
| Hunger | 12 weeks | Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale. |
| Satiety | 12 weeks | Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale. |
| Change in body weight | 12 weeks | Body weight will be assessed every every two weeks until week 12 |
Countries
Israel, Venezuela
Outcome results
None listed