High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

Type 2 Diabetes Clinical Trial

— PBD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02854202
• Other study ID #: HCCBI 017-2008-112
• Status: Active, not recruiting
• Phase: N/A
• First received: July 31, 2016
• Last updated: August 2, 2016
• Start date: August 2012
• Est. completion date: October 2016

Study information

• Verified date: July 2016
• Source: Hospital de Clinicas Caracas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 72 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas Caracas	Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose	Overall postprandial glycemia after breakfast, lunch and dinner	3 month	No
Secondary	Satiety	Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale.	3 month	No
Secondary	Change in body weight	Body weight will be assessed every every two weeks during 3 month	3 month	No