High Protein Breakfast on Postprandial Glycemia in T2D (PBD) (PBD)

August 2, 2016 updated by: Daniela Jakubowicz, MD, Hospital de Clinicas Caracas

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1-Whey protein
In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey
Other: Arm1: Whey protein
Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
Other Names:
  • WB
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
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
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
Other: Arm 3 Breakfast- low protein
Arm 3: Low protein' :The participants will consume 22 g protein at breakfast
Other Names:
  • LP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas Caracas

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: Daniela Jakubowicz, MD, Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCCBI 017-2008-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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