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
  Purpose
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

Condition Intervention
Type 2 Diabetes
Other: Arm 1 Whey Breakfast
Other: Arm 2 No Whey Breakfast
Other: Arm 3 Low Protein Breakfast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas Caracas:

Primary Outcome Measures:
  • Plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial plasma glucose after breakfast, lunch and dinner


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 58
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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

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

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01623648

Locations
Israel
Daniela Jakubowicz
Holon, N/A = Not Applicable, Israel, 58100
Venezuela
Daniela Jakubowicz
Caracas, San Bernardino, Venezuela, 410
Sponsors and Collaborators
Hospital de Clinicas Caracas
Tel Aviv University
Investigators
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
  More Information

Responsible Party: Daniela Jakubowicz, MD, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier: NCT01623648     History of Changes
Other Study ID Numbers: HCCCBI 017-2007-104 
Study First Received: June 18, 2012
Last Updated: July 3, 2016
Health Authority: Venezuela: Ethics Committee

Keywords provided by Hospital de Clinicas Caracas:
whey protein
hunger

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2016