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

Office of Human Research, Taipei Medical University

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: White sweet potato diet

Detailed Description

All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Normal diet with 1500~2000 kcal	Dietary supplement: White sweet potato diet; The diet were supplied 516 kcal daily
Experimental: Treatment Group; White sweet potato diet with 1500~2000 kcal	Dietary supplement: White sweet potato diet; The diet were supplied 516 kcal daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight After Intervention	Body weight change after 60 days intervention	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Fat After Intervention	Body fat change after 60 days intervention	60 days

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: N201604045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No