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

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

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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Arm 1 Whey Breakfast; Other: Arm 2 No Whey Breakfast; Other: Arm 3 Low Protein Breakfast

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • N/A = Not Applicable
    • Holon, N/A = Not Applicable, Israel, 58100
      • Daniela Jakubowicz
• Venezuela
  • San Bernardino
    • Caracas, San Bernardino, Venezuela, 410
      • Daniela Jakubowicz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Whey Breakfast; The arm 1 will be assigned to eating Whey protein in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein namely from whey at breakfast	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); Other Names: Whey
Active Comparator: Arm 2: No Whey Breakfast; The arm 2 will be assigned to intake other proteins (No Whey) in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein from other sources at breakfast	Other: 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); Other Names: No Whey
Placebo Comparator: Arm 3: Low Protein Breakfast; The arm 3 will be assigned to intake low protein and high carbohydrate breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 22 g protein from other sources at breakfast	Other: 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); Other Names: Low Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose	Postprandial plasma glucose after breakfast, lunch and dinner	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Insulin	Postprandial plasma insulin after breakfast lunch and dinner	12 weeks
Hunger	Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.	12 weeks
Satiety	Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.	12 weeks
Change in body weight	Body weight will be assessed every every two weeks until week 12	12 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas Caracas
• Collaborators: Tel Aviv University
• Investigators: Principal Investigator: Daniela Jakubowicz, MD, Hospital de Clínicas Caracas

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 3, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: whey protein; hunger
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: HCCCBI 017-2007-104