The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity
Office of Human Research, Taipei Medical University
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
April 17, 2019
CompletedApril 30, 2019
June 1, 2016
5 months
October 14, 2016
January 25, 2018
April 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Body Weight After Intervention
Body weight change after 60 days intervention
60 days
Secondary Outcomes (1)
Body Fat After Intervention
60 days
Study Arms (2)
Control Group
PLACEBO COMPARATORNormal diet with 1500\~2000 kcal
Treatment Group
EXPERIMENTALWhite sweet potato diet with 1500\~2000 kcal
Interventions
The diet were supplied 516 kcal daily
Eligibility Criteria
You may qualify if:
- ≦ BMI≦30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.
Results Point of Contact
- Title
- Dr. Sing-Chung Li
- Organization
- Taipei Medical University
Study Officials
- PRINCIPAL INVESTIGATOR
Chih-Han Lin, MS
Office of Human Research, Taipei Medical University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 17, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2016
Study Completion
May 1, 2017
Last Updated
April 30, 2019
Results First Posted
April 17, 2019
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share