Effect of Skate Skin Extract on Body Fat in Overweight Adults

NCT03409705 | Completed

• 1 other identifier: 02-2017-012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Body Fat

Outcome Measures

Primary Outcomes (1)

• Body fat percent

  Measured by DEXA

  Change from baseline body fat percent at 6, 12 weeks

Study Arms (2)

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

Skate Skin group DIETARY_SUPPLEMENT

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

Skate Skin group

Control group DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 23\~30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sang Yeoup Lee

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Head of Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF)

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 24, 2018
• Study Start: October 31, 2017
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

KR (1)