High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D

Type 2 Diabetes Clinical Trial

— HPB  

Official title:

Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01623648
• Other study ID #: HCCCBI 017-2007-104
• Status: Active, not recruiting
• Phase: N/A
• First received: June 18, 2012
• Last updated: July 3, 2016
• Start date: February 2013
• 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 the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals

Description:

Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie and protein breakfast promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression.

However the effect of isocaloric and isoproteic breakfast with different source of proteins, (whey vs other proteins or vs low protein in breakfast) on weight loss, appetite and on glycemic fluctuations after breakfast lunch and dinner was not explored in obese diabetic individuals.

To search whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast will lead to reduced hunger and overall postprandial glycemia and will enhance weight loss in obese diabetic individuals

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subjects =30 and =70 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. Those with anti-hypertensive and lipid-lowering medication will be included.

8. . Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months

10.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation.

12. Normal liver, kidney and thyroid function. 13. Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) > 60 mL/min/1.73 m2.

Exclusion Criteria:

1. Type 1 Diabetes

2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease

3. Anemia (Hg > 10 g/dL)

4. Serum creatinine level < 1.5 mg/dl

5. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.

6. 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

7. Infectious disease

8. Malignancy

9. Pregnant women or lactating

10. Known hypersensitivity to milk components

10. Participating in dietary program or using of weight-loss medications 11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

12. Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset

Study Design

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• Arm 1 Whey Breakfast
The patients will be assigned to eat 42 g protein namely from Whey protein in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
• Arm 2 No Whey Breakfast
The patients will be assigned to eat 42 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
• Arm 3 Low Protein Breakfast
The patients will be assigned to eat 22 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)

Locations

Country	Name	City	State
Israel	Daniela Jakubowicz	Holon	N/A = Not Applicable
Venezuela	Daniela Jakubowicz	Caracas	San Bernardino

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas Caracas	Tel Aviv University

Countries where clinical trial is conducted

Israel,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose	Postprandial plasma glucose after breakfast, lunch and dinner	12 weeks	No
Secondary	Plasma Insulin	Postprandial plasma insulin after breakfast lunch and dinner	12 weeks	No
Secondary	Hunger	Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.	12 weeks	No
Secondary	Satiety	Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.	12 weeks	No
Secondary	Change in body weight	Body weight will be assessed every every two weeks until week 12	12 weeks	No