An interventional study of Weight loss interventional study with 20% protein-diet and Weight loss interventional study with 27% protein-diet in Weight Loss, Obesity and Overweight, sponsored by Instituto Aragones de Ciencias de la Salud. Completed. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-01.
Sponsored by Instituto Aragones de Ciencias de la Salud · Not applicable, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 90 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Instituto Aragones de Ciencias de la Salud is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Weight loss interventional study with 20% protein-diet
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.
Behavioral: Weight loss interventional study with 27% protein-diet
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.
Behavioral: Weight loss interventional study with 35% protein-diet
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.
Time frame: After 3 months of intervention
Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women.
Time frame: After 3 months of intervention.
Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.
Time frame: After 3 months of intervention.
Change in blood pressure of diets with different protein composition in overweight and obese women.
Time frame: 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.
Time frame: 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.
Time frame: After 3 months of study completion.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Instituto Aragones de Ciencias de la Salud