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Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men

Primary Purpose

Men, Life Style, Lipid Metabolism Disorders

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 Men focused on measuring Dietary Formulations, Lifestyle, Obesity, Overweight, weight loss

Eligibility Criteria

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

Inclusion Criteria:

  • Non-smokers
  • Weight-stable (± 2 kg, for more than one year)
  • No history of regular exercise (in at least three months before the study).

Exclusion Criteria:

  • History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph
  • 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 (53 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 (51 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
    March 4, 2017
    Last Updated
    March 17, 2017
    Sponsor
    P.L.Shupik National Medical Academy of Post-Graduate Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03082794
    Brief Title
    Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men
    Official Title
    Investigating the Effects of Negative Calorie Diet Compared With Low-Calorie Diet on Weigh Loss and Lipid Profile in Sedentary Overweight/Obese Middle-Aged and Older Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 20, 2011 (Actual)
    Primary Completion Date
    September 20, 2012 (Actual)
    Study Completion Date
    December 27, 2012 (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

    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 in men.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Men, Life Style, Lipid Metabolism Disorders, Obesity, Overweight
    Keywords
    Dietary Formulations, Lifestyle, Obesity, Overweight, weight loss

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group I
    Arm Type
    Experimental
    Arm Description
    Study group I (53 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 (51 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
    Baseline
    Title
    Total cholesterol (Total-C)
    Description
    assessed in mg/dl
    Time Frame
    Baseline
    Title
    High-density lipoprotein -cholesterol (HDL-C)
    Description
    assessed in mg/dl
    Time Frame
    Baseline
    Title
    Low-density lipoprotein -cholesterol (LDL-C)
    Description
    assessed in mg/dl
    Time Frame
    Baseline
    Title
    Triglycerides (TG)
    Description
    assessed in mg/dl
    Time Frame
    Baseline
    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
    Male
    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 Weight-stable (± 2 kg, for more than one year) No history of regular exercise (in at least three months before the study). Exclusion Criteria: History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph 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 Men

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