Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments arm 1 whey breakfast, arm 2 no whey breakfast, arm 3 low protein breakfast
Sponsor Hospital de Clinicas Caracas
Collaborator Tel Aviv University
Start date February 2013
End date July 2016
Trial size 58 participants
Trial identifier NCT01623648, HCCCBI 017-2007-104

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
arm 1 whey breakfast Whey
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)
(Active Comparator)
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
arm 2 no whey breakfast No Whey
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)
(Placebo Comparator)
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
arm 3 low protein breakfast Low Protein
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)

Primary Outcomes

Measure
Plasma glucose
time frame: 12 weeks

Secondary Outcomes

Measure
Plasma Insulin
time frame: 12 weeks
Hunger
time frame: 12 weeks
Satiety
time frame: 12 weeks
Change in body weight
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
Principal investigator Daniela Jakubowicz, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hospital de Clinicas Caracas.