High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

Study Overview
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Brief Summary
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The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).

Detailed Description
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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.

Official Title
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Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Arm1: Whey protein
* Other: Arm 2 Breakfast- other proteins
* Other: Arm 3 Breakfast- low protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants: from 30 to 72 years of age BMI: 26 to 34 kg/m2) Diabetes criteria HbA1C: 7-9 % or Habitually eat breakfast Only naïve or treated with metformin. Not dieting and no change in body weight >10 lb = 4.5 kg within the last 3 months Normal liver, kidney and thyroid function. Exclusion Criteria: Type 1 Diabetes 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 Pregnant women or lactating Known hypersensitivity to milk components Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 72 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 protein<br>In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey | Other: Arm1: Whey protein<br>* Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast<br>* Other names: WB;|
| Active Comparator: Arm 2 Breakfast- other proteins<br>In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast | Other: Arm 2 Breakfast- other proteins<br>* Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast<br>* Other names: PB;|
| Placebo Comparator: Arm 3 Breakfast- low protein<br>In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast | Other: Arm 3 Breakfast- low protein<br>* Arm 3: Low protein' :The participants will consume 22 g protein at breakfast<br>* Other names: LP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose | Overall postprandial glycemia after breakfast, lunch and dinner | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale. | 3 month | 
| Change in body weight | Body weight will be assessed every every two weeks during 3 month | 3 month |