High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Whey Protein on Posprandial Glucose, Insulin GLP-1, GIP and DPP4 in Type 2 Diabetes

NCT01571622

Type 2 Diabetes Mellitus

COMPLETED NA

Effects of Whey Protein in Type 2 Diabetics

NCT01944449

Type 2 Diabetes

COMPLETED NA

Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

NCT01925248

Type 2 Diabetes Mellitus Hyperglycemia

COMPLETED NA

Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

NCT02180646

Type 2 Diabetes

COMPLETED NA

Whey Protein Effect on Glycaemic and Appetite Responses in T2D

NCT02903199

Type II Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1-Whey protein

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

Group Type EXPERIMENTAL

Arm1: Whey protein

Intervention Type OTHER

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

Arm 2 Breakfast- other proteins

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

Group Type ACTIVE_COMPARATOR

Arm 2 Breakfast- other proteins

Intervention Type OTHER

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

Arm 3 Breakfast- low protein

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

Group Type PLACEBO_COMPARATOR

Arm 3 Breakfast- low protein

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arm1: Whey protein

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

Intervention Type OTHER

Arm 2 Breakfast- other proteins

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

Intervention Type OTHER

Arm 3 Breakfast- low protein

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WB PB LP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants: from 30 to 72 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. Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 3 months
8. Normal liver, kidney and thyroid function.

Exclusion Criteria

1. Type 1 Diabetes
2. Anemia (Hg \> 10 g/dL)
3. Serum creatinine level \< 1.5 mg/dl
4. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
5. 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
6. Infectious disease
7. Pregnant women or lactating
8. Known hypersensitivity to milk components
9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

Minimum Eligible Age

30 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No