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| ID | Type | Description | Link |
|---|---|---|---|
| I+CS-HUMS-B80_PI13/00108 | Other Identifier | I+CS-HUMS-B80 |
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The objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20% protein hypocaloric diet | Active Comparator | Participants were advised with a hypocaloric diet with the following composition: 20% protein, 30% fat and 50% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. |
|
| 27% protein hypocaloric diet | Active Comparator | Participants were advised with a hypocaloric diet with the following composition: 27% protein, 30% fat and 43% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. |
|
| 35% protein hypocaloric diet | Active Comparator | Participants were advised with a hypocaloric diet with the following composition: 35% protein, 30% fat and 35% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss interventional study with 20% protein-diet | Behavioral |
| ||
| Weight loss interventional study with 27% protein-diet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. | The main outcome is to study the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from lean red meat, on body weight and lipid profile in overweight and obese women. | After 3 months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women. | After 3 months of intervention. | |
| Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure of diets with different protein composition in overweight and obese women. | After 3 months of intervention. | |
| Change in body weight of diets with different protein composition in overweight and obese women.. | In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Civeira, MD, PhD | Unidad de LÃpidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain) | Principal Investigator |
| Rocio Mateo-Gallego, MSc | Unidad de LÃpidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29329923 | Derived | Mateo-Gallego R, Lamiquiz-Moneo I, Perez-Calahorra S, Marco-Benedi V, Bea AM, Baila-Rueda L, Laclaustra M, Penalvo JL, Civeira F, Cenarro A. Different protein composition of low-calorie diet differently impacts adipokine profile irrespective of weight loss in overweight and obese women. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):133-142. doi: 10.1016/j.numecd.2017.10.024. Epub 2017 Nov 4. | |
| 26875447 |
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| Behavioral |
|
| Weight loss interventional study with 35% protein-diet | Behavioral |
|
| After 3 months of intervention. |
| After 3 months of study completion (at 6-months after beginning the study) |
| Change in adipokines concentration of diets with different protein composition in overweight and obese women. | In 3-months visits serum plasma, adipokines concentration will be determined. | After 3 months of study completion. |
| Derived |
| Mateo-Gallego R, Marco-Benedi V, Perez-Calahorra S, Bea AM, Baila-Rueda L, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Energy-restricted, high-protein diets more effectively impact cardiometabolic profile in overweight and obese women than lower-protein diets. Clin Nutr. 2017 Apr;36(2):371-379. doi: 10.1016/j.clnu.2016.01.018. Epub 2016 Jan 29. |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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