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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
Hospital de Clinicas Caracas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    July 31, 2016
    Last Updated
    August 2, 2016
    Sponsor
    Hospital de Clinicas Caracas
    Collaborators
    Tel Aviv University
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    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

    Learn more about this trial

    High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

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