High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

Overview

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

Full Title of Study: “Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

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

  • Other: Arm1: Whey protein
    • Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
  • 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: Arm 3 Breakfast- low protein
    • Arm 3: Low protein’ :The participants will consume 22 g protein at breakfast

Arms, Groups and Cohorts

  • Experimental: Arm 1-Whey protein
    • In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey
  • Active Comparator: Arm 2 Breakfast- other proteins
    • In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast
  • Placebo Comparator: Arm 3 Breakfast- low protein
    • In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast

Clinical Trial Outcome Measures

Primary Measures

  • Plasma glucose
    • Time Frame: 3 month
    • Overall postprandial glycemia after breakfast, lunch and dinner

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 72 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Clinicas Caracas
  • Collaborator
    • Tel Aviv University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daniela Jakubowicz, MD, Professor – Hospital de Clinicas Caracas
  • Overall Official(s)
    • Daniela Jakubowicz, MD, Principal Investigator, Wolfson Medical Center

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