Dietary Guide in Active Older Adult Men

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082807
• Other study ID #: no Grant 6
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: March 17, 2017
• Start date: February 25, 2011
• Est. completion date: December 15, 2012

Study information

• Verified date: March 2017
• Source: P.L.Shupik National Medical Academy of Post-Graduate Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 15, 2012
• Est. primary completion date: September 20, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• NCDsport
Negative Calorie Diet supplemented with exercise
• LCDsport
Low-Calorie diet with exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	assessed in kg	Baseline
Primary	Total cholesterol (Total-C)	assessed in mg/dl	Baseline
Primary	High-density lipoprotein -cholesterol (HDL-C)	assessed in mg/dl	Baseline
Primary	Low-density lipoprotein -cholesterol (LDL-C)	assessed in mg/dl	Baseline
Primary	Triglycerides (TG)	assessed in mg/dl	Baseline
Secondary	Weight	assessed in kg	3-month
Secondary	Total cholesterol (Total-C)	assessed in mg/dl	3-month
Secondary	High-density lipoprotein -cholesterol (HDL-C)	assessed in mg/dl	3-month
Secondary	Low-density lipoprotein -cholesterol (LDL-C)	assessed in mg/dl	3-month