High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

Hospital de Clinicas Caracas

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Other: Arm 3 Breakfast- low protein; Other: Arm 2 Breakfast- other proteins; Other: Arm1: Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT02854202

HCCBI 017-2008-112

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 72 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups, including a placebo group

Arm 1-Whey protein

Experimental group

Description:

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

Treatment:

Other: Arm1: Whey protein

Arm 2 Breakfast- other proteins

Active Comparator group

Description:

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

Treatment:

Other: Arm 2 Breakfast- other proteins

Arm 3 Breakfast- low protein

Placebo Comparator group

Description:

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

Treatment:

Other: Arm 3 Breakfast- low protein