Dietary Effects on Weight Loss and Lipid Profile in Sedentary Women
Primary Purpose
Obesity, Overweight, Life Style
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NCD
LCD
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity focused on measuring Caloric Restriction, Diet, Obesity, Overweight, Sedentary Lifestyle, Weight loss, Women
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study group I
Study group II
Arm Description
Study group I (19 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat). Both groups had 15% caloric restriction from their maintenance energy requirements.
Study group II (18 participants) received the LCD or healthy weight maintenance diet (details of diet: 15% protein, 55% carbohydrates, 30% fat).Both groups had 15% caloric restriction from their maintenance energy requirements.
Outcomes
Primary Outcome Measures
Weight
assessed in kg
Total cholesterol (Total-C)
assessed in mg/dl
High-density lipoprotein -cholesterol (HDL-C)
assessed in mg/dl
Low-density lipoprotein -cholesterol (LDL-C)
assessed in mg/dl
Triglycerides (TG)
assessed in mg/dl
Secondary Outcome Measures
Weight
assessed in kg
Total cholesterol (Total-C)
assessed in mg/dl
High-density lipoprotein -cholesterol (HDL-C)
assessed in mg/dl
Low-density lipoprotein -cholesterol (LDL-C)
assessed in mg/dl
Full Information
NCT ID
NCT03066882
First Posted
February 17, 2017
Last Updated
February 23, 2017
Sponsor
P.L.Shupik National Medical Academy of Post-Graduate Education
1. Study Identification
Unique Protocol Identification Number
NCT03066882
Brief Title
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Women
Official Title
Comparison Effects of Negative Calorie Diet and Low-calorie Diet on Weight Loss and Lipid Profile in Sedentary Overweight/Obese Middle-aged and Older Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 10, 2012 (Actual)
Primary Completion Date
September 20, 2015 (Actual)
Study Completion Date
October 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
P.L.Shupik National Medical Academy of Post-Graduate Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 on weight loss and lipid profile, and to compare its efficiency with low-calorie diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Life Style
Keywords
Caloric Restriction, Diet, Obesity, Overweight, Sedentary Lifestyle, Weight loss, Women
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group I
Arm Type
Experimental
Arm Description
Study group I (19 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat). Both groups had 15% caloric restriction from their maintenance energy requirements.
Arm Title
Study group II
Arm Type
Experimental
Arm Description
Study group II (18 participants) received the LCD or healthy weight maintenance diet (details of diet: 15% protein, 55% carbohydrates, 30% fat).Both groups had 15% caloric restriction from their maintenance energy requirements.
Intervention Type
Dietary Supplement
Intervention Name(s)
NCD
Other Intervention Name(s)
group I
Intervention Description
negative calorie diet
Intervention Type
Dietary Supplement
Intervention Name(s)
LCD
Other Intervention Name(s)
group II
Intervention Description
low calorie diet
Primary Outcome Measure Information:
Title
Weight
Description
assessed in kg
Time Frame
pre-study
Title
Total cholesterol (Total-C)
Description
assessed in mg/dl
Time Frame
pre-study
Title
High-density lipoprotein -cholesterol (HDL-C)
Description
assessed in mg/dl
Time Frame
pre-study
Title
Low-density lipoprotein -cholesterol (LDL-C)
Description
assessed in mg/dl
Time Frame
pre-study
Title
Triglycerides (TG)
Description
assessed in mg/dl
Time Frame
pre-study
Secondary Outcome Measure Information:
Title
Weight
Description
assessed in kg
Time Frame
3-month
Title
Total cholesterol (Total-C)
Description
assessed in mg/dl
Time Frame
3-month
Title
High-density lipoprotein -cholesterol (HDL-C)
Description
assessed in mg/dl
Time Frame
3-month
Title
Low-density lipoprotein -cholesterol (LDL-C)
Description
assessed in mg/dl
Time Frame
3-month
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants were 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.
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Women
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