- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623648
High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D (HPB)
Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects ≥30 and ≤70 years of age
- BMI: 26 to 34 kg/m2)
- Diabetes criteria
- HbA1C: 7-9 % or
- Habitually eat breakfast
- Only naïve or treated with metformin.
- Those with anti-hypertensive and lipid-lowering medication will be included.
- . 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:
- Type 1 Diabetes
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- Anemia (Hg > 10 g/dL)
- Serum creatinine level < 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- 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
- Infectious disease
- Malignancy
- Pregnant women or lactating
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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)
Other Names:
|
Active Comparator: 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
|
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)
Other Names:
|
Placebo Comparator: 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
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma glucose
Time Frame: 12 weeks
|
Postprandial plasma glucose after breakfast, lunch and dinner
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Insulin
Time Frame: 12 weeks
|
Postprandial plasma insulin after breakfast lunch and dinner
|
12 weeks
|
Hunger
Time Frame: 12 weeks
|
Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.
|
12 weeks
|
Satiety
Time Frame: 12 weeks
|
Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.
|
12 weeks
|
Change in body weight
Time Frame: 12 weeks
|
Body weight will be assessed every every two weeks until week 12
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniela Jakubowicz, MD, Hospital de Clínicas Caracas
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCCCBI 017-2007-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Arm 1 Whey Breakfast
-
Hospital de Clinicas CaracasTel Aviv UniversityUnknown
-
University of BathCompletedPhysical Activity | Weight Loss | Postprandial MetabolismUnited Kingdom
-
Tel Aviv UniversityCompletedType 2 Diabetes MellitusIsrael
-
University of BathCompletedAppetite | Postprandial MetabolismUnited Kingdom
-
Abbott NutritionCompletedDiabetes Mellitus, Type 2Thailand
-
Northumbria UniversityCompleted
-
Tel Aviv UniversityHospital de Clinicas CaracasCompleted
-
University of Colorado, DenverInternational Atomic Energy Agency; Universidad Autónoma de QuerétaroCompletedNutritional DeficiencyUnited States, Mexico
-
Northumbria UniversityCompleted