Type 2 Diabetes
Conditions
Brief summary
The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).
Detailed description
It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.
Interventions
OTHERArm1: Whey protein
Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
OTHERArm 2 Breakfast- other proteins
Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast
OTHERArm 3 Breakfast- low protein
Arm 3: Low protein' :The participants will consume 22 g protein at breakfast
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 72 Years
Healthy volunteers
No
Inclusion criteria
1. Participants: from 30 to 72 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. Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 3 months 8. Normal liver, kidney and thyroid function.
Exclusion criteria
1. Type 1 Diabetes 2. Anemia (Hg \> 10 g/dL) 3. Serum creatinine level \< 1.5 mg/dl 4. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery. 5. 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 6. Infectious disease 7. Pregnant women or lactating 8. Known hypersensitivity to milk components 9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose | 3 month | Overall postprandial glycemia after breakfast, lunch and dinner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety | 3 month | Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale. |
| Change in body weight | 3 month | Body weight will be assessed every every two weeks during 3 month |
Outcome results
None listed