Effect of Skate Skin Extract on Body Fat in Overweight Adults

Effect of Skate Skin Extract on Body Fat in Overweight Adults: A RCT

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

Study Overview

• Status: Completed
• Conditions: Body Fat
• Intervention / Treatment: Dietary supplement: Skate Skin group; Dietary supplement: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skate Skin group; 2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.	Dietary supplement: Skate Skin group; 2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.
Placebo Comparator: Control group; 2,000 mg of placebo was orally administered per day for 12 weeks.	Dietary supplement: Control group; 2,000 mg of starch was orally administered per day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 02-2017-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No