Effect of Skate Skin Extract on Body Fat in Overweight Ad... | NCT03409705

Studies
Effect of Skate Skin Extract on Body Fat in Overweight Adults

NCT03409705

Sponsor

Pusan National University Yangsan Hospital

Status

Completed

Last Update Posted

Feb 20, 2019Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Body Fat

Interventions

Skate Skin group
Control group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2017Actual

Primary Completion Date

May 31, 2018Actual

Completion Date

Jul 31, 2018Actual

First Submitted Date

Jan 10, 2018

First Submission Date that Met QC Criteria

Jan 17, 2018

First Posted Date

Jan 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2019

Last Update Posted Date

Feb 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults

Detailed Description

Our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults by a randomized, double-blind, and control-group study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Skate Skin group	Experimental	2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.	Dietary Supplement: Skate Skin group
Control group	Placebo Comparator	2,000 mg of placebo was orally administered per day for 12 weeks.	Dietary Supplement: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skate Skin group	Dietary Supplement	2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.	Skate Skin group

Measure	Description	Time Frame
Body fat percent	Measured by DEXA	Change from baseline body fat percent at 6, 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 23~30 kg/m2

Exclusion Criteria:

Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
Those who are treated with hypothyroidism or hyperthyroidism
Creatinine levels: more than twice the normal upper limit
AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
Participated in the commercial obesity program within the last 3 months.
If you have participated or are planning to participate in another clinical trial within the past month If yes
Alcohol abuser
Smoking abstinence within 3 months
If they are pregnant or lactating or have a pregnancy plan during the clinical trial
Those with allergic reactions to the constituent food
Any person deemed inappropriate by the researcher for other reasons

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design