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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03082781
Other study ID # No Grant 5
Secondary ID
Status Completed
Phase N/A
First received March 5, 2017
Last updated March 17, 2017
Start date October 10, 2012
Est. completion date August 15, 2013

Study information

Verified date March 2017
Source P.L.Shupik National Medical Academy of Post-Graduate Education
Contact n/a
Is FDA regulated No
Health authority
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 women with abnormal weight gain.


Description:

Background: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.

Objectives: 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 women with abnormal weight gain.

Material and Methods: Participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). They were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 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 66
Est. completion date August 15, 2013
Est. primary completion date June 20, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 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.

Study Design


Related Conditions & MeSH terms


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
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