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

Hospital de Clinicas Caracas

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Other: Arm 2 No Whey Breakfast; Other: Arm 1 Whey Breakfast; Other: Arm 3 Low Protein Breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT01623648

HCCCBI 017-2007-104

Details and patient eligibility

About

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

Full 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

Enrollment: 58 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

11. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 3 patient groups, including a placebo group

Arm 1 Whey Breakfast

Experimental group

Description:

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

Treatment:

Other: Arm 1 Whey Breakfast

Arm 2: No Whey Breakfast

Active Comparator group

Description:

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

Treatment:

Other: Arm 2 No Whey Breakfast

Arm 3: Low Protein Breakfast

Placebo Comparator group

Description:

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

Treatment:

Other: Arm 3 Low Protein Breakfast