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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier:
NCT01623648
First received: June 18, 2012
Last updated: July 3, 2016
Last verified: July 2016

June 18, 2012
July 3, 2016
February 2013
July 2016   (final data collection date for primary outcome measure)
Plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Postprandial plasma glucose after breakfast, lunch and dinner
Change in Body Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Subjects will be randomized to one of two isocaloric (1400 kcal) weight loss diets for 12 weeks: High Calorie Breakfast Diet BD or High Calorie Dinner Diet DD.
Complete list of historical versions of study NCT01623648 on ClinicalTrials.gov Archive Site
  • Plasma Insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial plasma insulin after breakfast lunch and dinner
  • Hunger [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.
  • Satiety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.
  • Change in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body weight will be assessed every every two weeks until week 12
Ghrelin suppression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
We will compare ghrelin supression after high calorie breakfast in the Breakfast Diet Group with ghrelin supression after high calorie dinner in the dinner diet group
Not Provided
Not Provided
 
High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D
Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • 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)
    Other Name: Whey
  • Other: 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)
    Other Name: No Whey
  • Other: 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)
    Other Name: Low Protein
  • 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
    Intervention: Other: Arm 1 Whey Breakfast
  • 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
    Intervention: Other: Arm 2 No Whey Breakfast
  • 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
    Intervention: Other: Arm 3 Low Protein Breakfast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
58
October 2016
July 2016   (final data collection date for primary outcome measure)

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

Both
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Venezuela
 
NCT01623648
HCCCBI 017-2007-104
Yes
Not Provided
Not Provided
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
Hospital de Clinicas Caracas
Tel Aviv University
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
Hospital de Clinicas Caracas
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP