Effect of Skate Skin Extract on Body Fat in Overweight Adults

Not Applicable

Completed

• Conditions: Body Fat
• Interventions: Dietary Supplement: Control group; Dietary Supplement: Skate Skin group

• Registration Number: NCT03409705
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Study Timeline

• Study Start: 2017-10-31
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Primary Completion: 2018-05-31
• Study Completion: 2018-07-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	2,000 mg of placebo was orally administered per day for 12 weeks.
Skate Skin group	Skate Skin group	2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Body fat percent	Change from baseline body fat percent at 6, 12 weeks	Measured by DEXA

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of