Clinical trial NCT01623648: High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D
Official title: Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: whey protein
hunger
Lead sponsor: Hospital de Clinicas Caracas
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2012-06-20
Enrollment: 58
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

-

Primary outcomes:
measure: Plasma glucose
timeFrame: 12 weeks
Secondary outcomes:
measure: Plasma Insulin
timeFrame: 12 weeks
measure: Hunger
timeFrame: 12 weeks
measure: Satiety
timeFrame: 12 weeks
measure: Change in body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Daniela Jakubowicz
state: N/A = Not Applicable
city: Caracas
country: Venezuela
facility: Daniela Jakubowicz
state: San Bernardino
Study officials:
affiliation: Hospital de Clinicas Caracas
name: Daniela Jakubowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: