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

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Arm 1 Whey Breakfast

Arm 2 No Whey Breakfast

Arm 3 Low Protein Breakfast

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring whey protein, hunger

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Daniela Jakubowicz
Daniela Jakubowicz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1 Whey Breakfast

Arm 2: No Whey Breakfast

Arm 3: Low Protein Breakfast

Arm Description

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 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 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

Outcomes

Primary Outcome Measures

Plasma glucose

Postprandial plasma glucose after breakfast, lunch and dinner

Secondary Outcome Measures

Plasma Insulin

Postprandial plasma insulin after breakfast lunch and dinner

Hunger

Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.

Satiety

Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.

Change in body weight

Body weight will be assessed every every two weeks until week 12

Full Information

NCT ID

NCT01623648

First Posted

June 18, 2012

Last Updated

July 3, 2016

Sponsor

Hospital de Clinicas Caracas

Collaborators

Tel Aviv University

1. Study Identification

Unique Protocol Identification Number

NCT01623648

Brief Title

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

Acronym

HPB

Official Title

Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Clinicas Caracas

Collaborators

Tel Aviv University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

whey protein, hunger

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 Whey Breakfast

Arm Type

Experimental

Arm Description

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 Title

Arm 2: No Whey Breakfast

Arm Type

Active Comparator

Arm Description

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 Title

Arm 3: Low Protein Breakfast

Arm Type

Placebo Comparator

Arm Description

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 Type

Other

Intervention Name(s)

Arm 1 Whey Breakfast

Other Intervention Name(s)

Whey

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Arm 2 No Whey Breakfast

Other Intervention Name(s)

No Whey

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Arm 3 Low Protein Breakfast

Other Intervention Name(s)

Low Protein

Intervention Description

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 Outcome Measure Information:

Title

Plasma glucose

Description

Postprandial plasma glucose after breakfast, lunch and dinner

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Plasma Insulin

Description

Postprandial plasma insulin after breakfast lunch and dinner

Time Frame

12 weeks

Title

Hunger

Description

Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.

Time Frame

12 weeks

Title

Satiety

Description

Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.

Time Frame

12 weeks

Title

Change in body weight

Description

Body weight will be assessed every every two weeks until week 12

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniela Jakubowicz, MD

Organizational Affiliation

Hospital de Clinicas Caracas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Daniela Jakubowicz

City

Holon

State/Province

N/A = Not Applicable

ZIP/Postal Code

58100

Country

Israel

Facility Name

Daniela Jakubowicz

City

Caracas

State/Province

San Bernardino

ZIP/Postal Code

410

Country

Venezuela

12. IPD Sharing Statement

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

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