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Dietary Guide in Active Older Adult Men

Primary Purpose

Men, Diet Modification, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NCDsport
LCDsport
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 Caloric Restriction, Diet, Exercise, Obesity, Overweight, Sedentary lifestyle, weight loss, Men

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleAccepts 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 (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.

    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.

    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 7, 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
    NCT03082807
    Brief Title
    Dietary Guide in Active Older Adult Men
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 25, 2011 (Actual)
    Primary Completion Date
    September 20, 2012 (Actual)
    Study Completion Date
    December 15, 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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 men with abnormal weight gain.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Men, Diet Modification, Obesity, Overweight, Life Style, Weight Loss
    Keywords
    Caloric Restriction, Diet, Exercise, Obesity, Overweight, Sedentary lifestyle, weight loss, Men

    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 (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.
    Arm Title
    Study group II
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    NCDsport
    Other Intervention Name(s)
    group I
    Intervention Description
    Negative Calorie Diet supplemented with exercise
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    LCDsport
    Other Intervention Name(s)
    group II
    Intervention Description
    Low-Calorie diet with exercise
    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 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 Guide in Active Older Adult Men

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