Dietary Guide in Active Older Adult Men

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss; Diet Modification; Life Style; Men
• Intervention / Treatment: Dietary supplement: NCDsport; Dietary supplement: LCDsport

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: NCDsport; Negative Calorie Diet supplemented with exercise; Other Names: group I
Experimental: 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.	Dietary supplement: LCDsport; Low-Calorie diet with exercise; Other Names: group II

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2011
• Primary Completion (Actual): September 20, 2012
• Study Completion (Actual): December 15, 2012

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Overweight; Diet; weight loss; Men; Sedentary lifestyle; Caloric Restriction
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: no Grant 6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No