Dietary Guide in Active Older Adult Men

NCT ID: NCT03082807

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-25
• Study Completion Date: 2012-12-15

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.

Conditions

Men; Diet Modification; Obesity; Overweight; Life Style; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Study group I

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.

Group Type: EXPERIMENTAL

NCDsport

Intervention Type: DIETARY_SUPPLEMENT

Negative Calorie Diet supplemented with exercise

Study group II

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.

Group Type: EXPERIMENTAL

LCDsport

Intervention Type: DIETARY_SUPPLEMENT

Low-Calorie diet with exercise

Interventions

NCDsport

Negative Calorie Diet supplemented with exercise

Intervention Type: DIETARY_SUPPLEMENT

LCDsport

Low-Calorie diet with exercise

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

group I; group II

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

P.L.Shupik National Medical Academy of Post-Graduate Education

OTHER

Sponsor Role: lead

Responsible Party

Mohammadreza Rezaeipour, MD, PhD

Asst. Prof. of sports medicine (sports injury and corrective movement)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

no Grant 6

Identifier Type: -

Identifier Source: org_study_id