High Protein Breakfast on Postprandial Glycemia in T2D (PBD) (PBD)
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arm1: Whey protein
Arm 2 Breakfast- other proteins
Arm 3 Breakfast- low protein
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1-Whey protein
Arm 2 Breakfast- other proteins
Arm 3 Breakfast- low protein
Arm Description
In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey
In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast
In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast
Outcomes
Primary Outcome Measures
Plasma glucose
Overall postprandial glycemia after breakfast, lunch and dinner
Secondary Outcome Measures
Satiety
Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale.
Change in body weight
Body weight will be assessed every every two weeks during 3 month
Full Information
NCT ID
NCT02854202
First Posted
July 31, 2016
Last Updated
August 2, 2016
Sponsor
Hospital de Clinicas Caracas
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT02854202
Brief Title
High Protein Breakfast on Postprandial Glycemia in T2D (PBD)
Acronym
PBD
Official Title
Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas Caracas
Collaborators
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1-Whey protein
Arm Type
Experimental
Arm Description
In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey
Arm Title
Arm 2 Breakfast- other proteins
Arm Type
Active Comparator
Arm Description
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 Title
Arm 3 Breakfast- low protein
Arm Type
Placebo Comparator
Arm Description
In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast
Intervention Type
Other
Intervention Name(s)
Arm1: Whey protein
Other Intervention Name(s)
WB
Intervention Description
Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
Intervention Type
Other
Intervention Name(s)
Arm 2 Breakfast- other proteins
Other Intervention Name(s)
PB
Intervention Description
Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast
Intervention Type
Other
Intervention Name(s)
Arm 3 Breakfast- low protein
Other Intervention Name(s)
LP
Intervention Description
Arm 3: Low protein' :The participants will consume 22 g protein at breakfast
Primary Outcome Measure Information:
Title
Plasma glucose
Description
Overall postprandial glycemia after breakfast, lunch and dinner
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Satiety
Description
Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale.
Time Frame
3 month
Title
Change in body weight
Description
Body weight will be assessed every every two weeks during 3 month
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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High Protein Breakfast on Postprandial Glycemia in T2D (PBD)
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