Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18%-Protein diet | Active Comparator | Energy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates |
|
| 35%-Protein diet | Active Comparator | Energy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss interventional study with a low-calorie 18%-protein diet | Behavioral |
| ||
| Weight loss interventional study with a low-calorie 35%-protein diet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose. | After 3 and 6 months of intervention. | |
| Change in glycated hemoglobin. | After 3 and 6 months of intervention. | |
| Change in insulin resistance (HOMA index). | After 3 and 6 months of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight. | After 3 and 6 months of intervention. | |
| Change in body composition. | After 3 and 6 months of intervention. | |
| Change in waist circumference. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Civeira, MD, PhD | Contact | +34 976765500 | 2884 | civeira@unizar.es |
| Rocio Mateo-Gallego, RD, PhD | Contact | rmateo.iacs@aragon.es |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Civeira, MD, PhD | Unidad ClÃnica y de Investigación en LÃpidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fernando Civeira | Recruiting | Zaragoza | Zaragoza | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31255349 | Derived | Marco-Benedi V, Perez-Calahorra S, Bea AM, Lamiquiz-Moneo I, Baila-Rueda L, Cenarro A, Civeira F, Mateo-Gallego R. High-protein energy-restricted diets induce greater improvement in glucose homeostasis but not in adipokines comparing to standard-protein diets in early-onset diabetic adults with overweight or obesity. Clin Nutr. 2020 May;39(5):1354-1363. doi: 10.1016/j.clnu.2019.06.005. Epub 2019 Jun 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
| After 3 and 6 months of intervention. |
| Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins). | After 3 and 6 months of intervention. |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided