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CompletedNCT03409705Updated Feb 20, 2019

Effect of Skate Skin Extract on Body Fat in Overweight Adults

An interventional study of Skate Skin group and Control group in Body Fat, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Body Fat

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03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI 23\~30 kg/m2

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Control group

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

    Dietary Supplement: Control group

Interventions

  • Dietary supplementSkate Skin group

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

  • Dietary supplementControl group

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

05

What researchers measure

Primary outcomes

  1. Body fat percent

    Measured by DEXA

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

06

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeungsangnam-do 50612, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03409705
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sang Yeoup Lee (Principal Investigator, Professor, Head of Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF), Pusan National University Yangsan Hospital) — Principal investigator
First posted
Jan 24, 2018
Start date
Oct 31, 2017
Primary completion
May 31, 2018
Completion
Jul 31, 2018
Last update
Feb 20, 2019

Study contacts

Sang Yeoup Lee
principal investigator · Pusan National University Yangsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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