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Completed

NCT Number: NCT03409705

Effect of Skate Skin Extract on Body Fat in Overweight Adults

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

Completed

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skate Skin group

Dietary Supplement

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

Control group

Dietary Supplement

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

Primary outcomes

  1. Body fat percent

    Time frame: Change from baseline body fat percent at 6, 12 weeks

    Measured by DEXA

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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