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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
P.L.Shupik National Medical Academy of Post-Graduate Education
About
Eligibility
Locations
Arms
Outcomes
Full info

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

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    February 17, 2017
    Last Updated
    February 23, 2017
    Sponsor
    P.L.Shupik National Medical Academy of Post-Graduate Education
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    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

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    Dietary Effects on Weight Loss and Lipid Profile in Sedentary Women

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