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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Other: Arm 2 No Whey Breakfast; Other: Arm 3 Low Protein Breakfast; Other: Arm 1 Whey Breakfast

• Registration Number: NCT01623648
• Lead Sponsor: Hospital de Clinicas Caracas

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

Study Timeline

• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Study Start: 2013-02
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Last Update Submitted: 2016-07-03
• Last Update Posted: 2016-07-06
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Subjects ≥30 and ≤70 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. Those with anti-hypertensive and lipid-lowering medication will be included.
8. . 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

1. Type 1 Diabetes

2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease

3. Anemia (Hg > 10 g/dL)

4. Serum creatinine level < 1.5 mg/dl

5. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.

6. 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

7. Infectious disease

8. Malignancy

9. Pregnant women or lactating

10. Known hypersensitivity to milk components

11. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: No Whey Breakfast	Arm 2 No Whey 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
Arm 3: Low Protein Breakfast	Arm 3 Low Protein 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
Arm 1 Whey Breakfast	Arm 1 Whey Breakfast	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

Primary Outcome Measures

Name	Time	Method
Plasma glucose	12 weeks	Postprandial plasma glucose after breakfast, lunch and dinner

Secondary Outcome Measures

Name	Time	Method
Plasma Insulin	12 weeks	Postprandial plasma insulin after breakfast lunch and dinner
Hunger	12 weeks	Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.
Satiety	12 weeks	Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.
Change in body weight	12 weeks	Body weight will be assessed every every two weeks until week 12

Trial Locations

Locations (1)

Daniela Jakubowicz; 🇻🇪 Caracas, San Bernardino, Venezuela