OverweightNCT02935179

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

A study testing White sweet potato diet in people with Overweight, run by Taipei Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Overweight
What is being tested?: White sweet potato diet
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Jul 2016to May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

24≦ BMI≦30

Who cannot join

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

About this study

Official title: 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.

Read the detailed description

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

Conditions: Overweight
Being tested: White sweet potato diet
Medical subject headings: Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

White sweet potato dietDietary supplement
The diet were supplied 516 kcal daily

Study groups in NCT02935179
Study group	Role	What they receive
Control Group	Placebo comparator	Normal diet with 1500~2000 kcal Receives: Dietary Supplement: White sweet potato diet
Treatment Group	Experimental	White sweet potato diet with 1500~2000 kcal Receives: Dietary Supplement: White sweet potato diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight After Intervention
Body weight change after 60 days intervention
Measured: 60 days

Secondary outcomes (1)

Body Fat After Intervention
Body fat change after 60 days intervention
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016May 2017

First posted17 Oct 2016 (estimated)
Study startJul 2016
Primary completionDec 2016
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OverweightStudies of the same condition, open and under way.
More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02935179
Sponsor's protocol ID: N201604045
Status last verified: Jun 2016
First submitted: 14 Oct 2016
Last updated: 30 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Overweight trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Office of Human Research, Taipei Medical University
ClinicalTrials.gov ID: NCT02935179
Acronym / sponsor ID: N201604045
Conditions: Overweight
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Taipei Medical UniversityUniversity, hospital or other
Study start: Jul 2016
Primary completion: Dec 2016 (actual)
Study completion: May 2017 (actual)
First posted: 17 Oct 2016 (estimated)
Results: Posted 17 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Group	Placebo comparator	Dietary Supplement: White sweet potato dietNormal diet with 1500~2000 kcal
Treatment Group	Experimental	Dietary Supplement: White sweet potato dietWhite sweet potato diet with 1500~2000 kcal

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

24≦ BMI≦30

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
White sweet potato dietThe diet were supplied 516 kcal daily	Dietary supplement	Control Group, Treatment Group

Primary outcome

Body Weight After Intervention
Time frame: 60 days
Body weight change after 60 days intervention

1 secondary outcome

Body Fat After Intervention
Time frame: 60 days

Results and safety

Results posted to the registry on 17 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	30	29
Treatment Group	30	29

Primary outcome: Body Weight After Intervention

Time frame: 60 days. Mean (Standard Deviation). Unit: Kg

Measure	Control Group n = 29	Treatment Group n = 29
Value	-2.11 (1.7)	-3.7 (2.24)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The adverse event data were collected from the participants during intervention and assessed after 24 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Treatment Group	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Limitations and caveats (from the sponsor): Small sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Overweight

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chih-Han Lin, MS principal investigator

Office of Human Research, Taipei Medical University

Questions about this trial

What is this clinical trial studying?

A study testing White sweet potato diet in people with Overweight, run by Taipei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight After Intervention (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935179.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.