Trial | NCT02854202  Report issue

Title

High Protein Breakfast on Postprandial Glycemia in T2D (PBD)
Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Arm1: Whey protein ...

  • Study Participants

    60
The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).
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.
Study Started
Aug 31
2012
Primary Completion
Dec 31
2014
Study Completion
Oct 31
2016
Anticipated
Last Update
Aug 03
2016
Estimate

Other Arm1: Whey protein

Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast

  • Other names: WB

Other Arm 2 Breakfast- other proteins

Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast

  • Other names: PB

Other Arm 3 Breakfast- low protein

Arm 3: Low protein' :The participants will consume 22 g protein at breakfast

  • Other names: LP

Arm 1-Whey protein Experimental

In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey

Arm 2 Breakfast- other proteins Active Comparator

In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast

Arm 3 Breakfast- low protein Placebo Comparator

In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast

Criteria 

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.
No Results Posted