NCT01623648

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

3.4 years

First QC Date

June 18, 2012

Last Update Submit

July 3, 2016

Conditions

Type 2 Diabetes

Keywords

whey proteinhunger

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose

    Postprandial plasma glucose after breakfast, lunch and dinner

    12 weeks

Secondary Outcomes (4)

  • Plasma Insulin

    12 weeks

  • Hunger

    12 weeks

  • Satiety

    12 weeks

  • Change in body weight

    12 weeks

Study Arms (3)

Arm 1 Whey Breakfast

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

Other: Arm 1 Whey Breakfast

Arm 2: No Whey Breakfast

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

Other: Arm 2 No Whey Breakfast

Arm 3: Low Protein Breakfast

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

Other: Arm 3 Low Protein Breakfast

Interventions

Arm 1 Whey BreakfastOTHER

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)

Also known as: Whey
Arm 1 Whey Breakfast
Arm 2 No Whey BreakfastOTHER

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)

Also known as: No Whey
Arm 2: No Whey Breakfast
Arm 3 Low Protein BreakfastOTHER

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)

Also known as: Low Protein
Arm 3: Low Protein Breakfast

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation.
  • \. Normal liver, kidney and thyroid function. 13. Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) \> 60 mL/min/1.73 m2.

You may not qualify if:

  • 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
  • \. Participating in dietary program or using of weight-loss medications 11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
  • \. Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Daniela Jakubowicz

Holon, N/A = Not Applicable, 58100, Israel

Location

Daniela Jakubowicz

Caracas, San Bernardino, 410, Venezuela

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

WheyDiet, Protein-Restricted

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological Phenomena

Study Officials

  • Daniela Jakubowicz, MD

    Hospital de Clinicas Caracas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

February 1, 2013

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

IL(1)VE(1)