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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01623648
Other study ID # HCCCBI 017-2007-104
Secondary ID
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


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
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