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Effect of Skate Skin Extract on Body Fat in Overweight Adults

Primary Purpose

Body Fat

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Skate Skin group
Control group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Fat

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Skate Skin group

Control group

Arm Description

2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.

2,000 mg of placebo was orally administered per day for 12 weeks.

Outcomes

Primary Outcome Measures

Body fat percent
Measured by DEXA

Secondary Outcome Measures

Full Information

First Posted
January 10, 2018
Last Updated
February 18, 2019
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03409705
Brief Title
Effect of Skate Skin Extract on Body Fat in Overweight Adults
Official Title
Effect of Skate Skin Extract on Body Fat in Overweight Adults: A RCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skate Skin group
Arm Type
Experimental
Arm Description
2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
2,000 mg of placebo was orally administered per day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Skate Skin group
Intervention Description
2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Intervention Description
2,000 mg of starch was orally administered per day for 12 weeks.
Primary Outcome Measure Information:
Title
Body fat percent
Description
Measured by DEXA
Time Frame
Change from baseline body fat percent at 6, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Skate Skin Extract on Body Fat in Overweight Adults

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