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

NCT ID: NCT01623648

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-10-31

Brief 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

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Arm 1 Whey Breakfast

Intervention Type: OTHER

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 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

Group Type: ACTIVE_COMPARATOR

Arm 2 No Whey Breakfast

Intervention Type: OTHER

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 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

Group Type: PLACEBO_COMPARATOR

Arm 3 Low Protein Breakfast

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: OTHER

Other Intervention Names

Whey; No Whey; Low Protein

Eligibility Criteria

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

-

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Hospital de Clinicas Caracas

OTHER

Sponsor Role: lead

Responsible Party

Daniela Jakubowicz, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Jakubowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas Caracas

Locations

Daniela Jakubowicz

Holon, N/A = Not Applicable, Israel

Daniela Jakubowicz

Caracas, San Bernardino, Venezuela

Countries

Israel; Venezuela

Other Identifiers

HCCCBI 017-2007-104

Identifier Type: -

Identifier Source: org_study_id