Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments arm1: whey protein, arm 2 breakfast- other proteins, arm 3 breakfast- low protein
Sponsor Hospital de Clinicas Caracas
Collaborator Tel Aviv University
Start date August 2012
End date December 2014
Trial size 60 participants
Trial identifier NCT02854202, HCCBI 017-2008-112

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey
arm1: whey protein WB
Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
(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 2 breakfast- other proteins PB
Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast
(Placebo Comparator)
In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast
arm 3 breakfast- low protein LP
Arm 3: Low protein' :The participants will consume 22 g protein at breakfast

Primary Outcomes

Measure
Plasma glucose
time frame: 3 month

Secondary Outcomes

Measure
Satiety
time frame: 3 month
Change in body weight
time frame: 3 month

Eligibility Criteria

Male or female participants from 30 years up to 72 years old.

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.

Additional Information

Official title Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes
Principal investigator Daniela Jakubowicz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital de Clinicas Caracas.