Dietary Guide in Active Older Adult Men

Study Overview
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Brief Summary
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The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain.

Detailed Description
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Background and Aim: 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 supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain. Materials and Methods: Participants included sedentary men (age 45-75 years) with overweight or obesity (n=37). They were randomly divided into 2 groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 37 participants, 30 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Official Title
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Investigating the Effects of Negative Calorie Diet Compared With Low-calorie Diet Under Exercise Condition on Weight Loss and Lipid Profile in Overweight/Obese Middle-aged and Older Men

Conditions
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Men, Diet Modification, Obesity, Overweight, Life Style, Weight Loss

Intervention / Treatment
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* Dietary Supplement: NCDsport
* Dietary Supplement: LCDsport


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study. Exclusion Criteria: History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any 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 (18 participants) received the NCD with exercise (NCDsport). This groups had 5% caloric restriction from their maintenance energy requirements and 10% increase in energy expenditure through structured regular exercise. | Dietary Supplement: NCDsport<br>* Negative Calorie Diet supplemented with exercise<br>* Other names: group I;|
| Experimental: Study group II<br>Study group II (19 participants) received the low-calorie diet with exercise (LCDsport). This groups had 5% caloric restriction from their maintenance energy requirements and 10% increase in energy expenditure through structured regular exercise. | Dietary Supplement: LCDsport<br>* Low-Calorie diet with exercise<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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Men, Caloric Restriction, Diet, Exercise, Obesity, Overweight, Sedentary lifestyle, weight loss