NCT02854202

Brief Summary

The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable type-2-diabetes

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

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

July 31, 2016

Last Update Submit

August 2, 2016

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose

    Overall postprandial glycemia after breakfast, lunch and dinner

    3 month

Secondary Outcomes (2)

  • Satiety

    3 month

  • Change in body weight

    3 month

Study Arms (3)

Arm 1-Whey protein

EXPERIMENTAL

In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey

Other: Arm1: Whey protein

Arm 2 Breakfast- other proteins

ACTIVE COMPARATOR

In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast

Other: Arm 2 Breakfast- other proteins

Arm 3 Breakfast- low protein

PLACEBO COMPARATOR

In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast

Other: Arm 3 Breakfast- low protein

Interventions

Arm1: Whey proteinOTHER

Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast

Also known as: WB
Arm 1-Whey protein
Arm 2 Breakfast- other proteinsOTHER

Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast

Also known as: PB
Arm 2 Breakfast- other proteins
Arm 3 Breakfast- low proteinOTHER

Arm 3: Low protein' :The participants will consume 22 g protein at breakfast

Also known as: LP
Arm 3 Breakfast- low protein

Eligibility Criteria

Age30 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants: from 30 to 72 years of age
  • BMI: 26 to 34 kg/m2)
  • Diabetes criteria
  • HbA1C: 7-9 % or
  • Habitually eat breakfast
  • Only naïve or treated with metformin.
  • Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 3 months
  • Normal liver, kidney and thyroid function.

You may not qualify if:

  • Type 1 Diabetes
  • 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
  • Pregnant women or lactating
  • Known hypersensitivity to milk components
  • Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daniela Jakubowicz, MD

    Wolfson Medical Center

    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
Professor

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 3, 2016

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

October 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share