Dietary Guide in Active Older Adult Men

Not Applicable

Completed

• Conditions: Diet Modification; Life Style; Weight Loss; Men; Obesity; Overweight
• Interventions: Dietary Supplement: LCDsport; Dietary Supplement: NCDsport

• Registration Number: NCT03082807
• Lead Sponsor: P.L.Shupik National Medical Academy of Post-Graduate Education

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02-25
• Primary Completion: 2012-09-20
• Study Completion: 2012-12-15
• Status Verified: 2017-03
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-12
• Study First Posted: 2017-03-17
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group II	LCDsport	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.
Study group I	NCDsport	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.

Primary Outcome Measures

Name	Time	Method
Weight	Baseline	assessed in kg
Total cholesterol (Total-C)	Baseline	assessed in mg/dl
High-density lipoprotein -cholesterol (HDL-C)	Baseline	assessed in mg/dl
Low-density lipoprotein -cholesterol (LDL-C)	Baseline	assessed in mg/dl
Triglycerides (TG)	Baseline	assessed in mg/dl

Secondary Outcome Measures

Name	Time	Method
Total cholesterol (Total-C)	3-month	assessed in mg/dl
High-density lipoprotein -cholesterol (HDL-C)	3-month	assessed in mg/dl
Weight	3-month	assessed in kg
Low-density lipoprotein -cholesterol (LDL-C)	3-month	assessed in mg/dl