Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men

Study Overview
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Brief Summary
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Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with low-calorie diet in men.

Official Title
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Investigating the Effects of Negative Calorie Diet Compared With Low-Calorie Diet on Weigh Loss and Lipid Profile in Sedentary Overweight/Obese Middle-Aged and Older Men

Conditions
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Men, Life Style, Lipid Metabolism Disorders, Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: NCD
* Dietary Supplement: LCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smokers Weight-stable (± 2 kg, for more than one year) No history of regular exercise (in at least three months before the study). Exclusion Criteria: History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group I<br>Study group I (53 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat). Both groups had 15% caloric restriction from their maintenance energy requirements. | Dietary Supplement: NCD<br>* Negative Calorie Diet<br>* Other names: group I;|
| Experimental: Study group II<br>Study group II (51 participants) received the LCD or healthy weight maintenance diet (details of diet: 15% protein, 55% carbohydrates, 30% fat).Both groups had 15% caloric restriction from their maintenance energy requirements. | Dietary Supplement: LCD<br>* Low Calorie Diet<br>* Other names: group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | assessed in kg | Baseline | 
| Total cholesterol (Total-C) | assessed in mg/dl | Baseline | 
| High-density lipoprotein -cholesterol (HDL-C) | assessed in mg/dl | Baseline | 
| Low-density lipoprotein -cholesterol (LDL-C) | assessed in mg/dl | Baseline | 
| Triglycerides (TG) | assessed in mg/dl | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | assessed in kg | 3-month | 
| Total cholesterol (Total-C) | assessed in mg/dl | 3-month | 
| High-density lipoprotein -cholesterol (HDL-C) | assessed in mg/dl | 3-month | 
| Low-density lipoprotein -cholesterol (LDL-C) | assessed in mg/dl | 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Dietary Formulations, Lifestyle, Overweight, weight loss