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The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
White sweet potato diet
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 24≦ BMI≦30

Exclusion Criteria:

  • Pregnant and lactating women
  • Patients within six months after surgery
  • Mental illness or depression
  • Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases
  • Those who have taken "additional nutritional supplements" habit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control Group

    Treatment Group

    Arm Description

    Normal diet with 1500~2000 kcal

    White sweet potato diet with 1500~2000 kcal

    Outcomes

    Primary Outcome Measures

    Body Weight After Intervention
    Body weight change after 60 days intervention

    Secondary Outcome Measures

    Body Fat After Intervention
    Body fat change after 60 days intervention

    Full Information

    First Posted
    October 14, 2016
    Last Updated
    April 17, 2019
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02935179
    Brief Title
    The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity
    Official Title
    Office of Human Research, Taipei Medical University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and health food that to do functional study in Shih Chien University and Taipei Medical University. In this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days.
    Detailed Description
    All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Normal diet with 1500~2000 kcal
    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    White sweet potato diet with 1500~2000 kcal
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    White sweet potato diet
    Intervention Description
    The diet were supplied 516 kcal daily
    Primary Outcome Measure Information:
    Title
    Body Weight After Intervention
    Description
    Body weight change after 60 days intervention
    Time Frame
    60 days
    Secondary Outcome Measure Information:
    Title
    Body Fat After Intervention
    Description
    Body fat change after 60 days intervention
    Time Frame
    60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 24≦ BMI≦30 Exclusion Criteria: Pregnant and lactating women Patients within six months after surgery Mental illness or depression Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases Those who have taken "additional nutritional supplements" habit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chih-Han Lin, MS
    Organizational Affiliation
    Office of Human Research, Taipei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity

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