ObesityNCT03842774
Efficacy and Safety of Extract of Gelidium Elegans
A study testing Exract of Gelidium elegans in people with Obesity, run by Yonsei University at 1 site in South Korea.
Trial summary
Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing body fat. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exract of Gelidium elegans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Nov 2017to 23 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Between the ages of 19 and 50
- 2. BMI is at or greater than 23 and less than 30 kg/m^2
Who cannot join
- 1. uncontrolled hypertension
- 2. uncontrolled diabetes
- 3. current serious cerebrovascular and cardiovascular disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University
Seoul
About this study
Official title: Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing body fat. In a preliminary study of obese adults aged 20 years or older, the extracts of Gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase lean body mass. Based on these results, we tried to confirm the effect of body weight and body fat reduction of Gelidium elegans extract in overweight and obese people.
- Conditions
- Obesity
- Being tested
- Exract of Gelidium elegans, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exract of Gelidium elegansDietary supplement
Exract of Gelidium elegans will be given to the test group.
PlaceboDietary supplement
Placebo supplement will be given to the test group.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | taken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks Receives: Dietary Supplement: Exract of Gelidium elegans |
| Control group | Placebo comparator | taken 3 tablets of placebo once a day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body fat mass by DEXA after 12-week treatment
Measured: 12 week
change in visceral, subcutaneous, total fat area and ratio of visceral and subcutaneous fat area will be combined to report by Fat CT after 12-week treatment
Measured: 12 week
Secondary outcomes (22)
change in body weight and body fat mass will be combined to report by Bio-impedance
Measured: 6 week
change in body weight and body fat mass will be combined to report by Bio-impedance
Measured: 12 week
change in waist circumference
Measured: 6 week
change in waist circumference
Measured: 12 week
change in hip circumference
Measured: 6 week
change in hip circumference
Measured: 12 week
change in ratio of waist and hip circumference
Measured: 6 week
change in ratio of waist and hip circumference
Measured: 12 week
body mass index
Measured: 6 week
body mass index
Measured: 12 week
change in lean body mass by DEXA
Measured: 6 week
change in lean body mass by DEXA
Measured: 12 week
change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile
Measured: 6 week
change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile
Measured: 12 week
change in laboratory test result of CRP
Measured: 6 week
change in laboratory test result of CRP
Measured: 12 week
change in laboratory test result of fasting insulin
Measured: 6 week
change in laboratory test result of fasting insulin
Measured: 12 week
change in HOMA-IR
Measured: 6 week
change in HOMA-IR
Measured: 12 week
change in HOMA-beta
Measured: 6 week
change in HOMA-beta
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start8 Nov 2017
- Primary completion17 May 2018
- Study completion23 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842774
- Sponsor's protocol ID
- 4-2017-0860
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
- ClinicalTrials.gov ID
- NCT03842774
- Acronym / sponsor ID
- 4-2017-0860
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing body fat. In a preliminary study of obese adults aged 20 years or older, the extracts of Gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase lean body mass. Based on these results, we tried to confirm the effect of body weight and body fat reduction of Gelidium elegans extract in overweight and obese people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Dietary Supplement: Exract of Gelidium eleganstaken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks |
| Control group | Placebo comparator | Dietary Supplement: Placebotaken 3 tablets of placebo once a day for 12 weeks |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Between the ages of 19 and 50
- 2. BMI is at or greater than 23 and less than 30 kg/m^2
Key exclusion criteria (3 listed)
- 1. uncontrolled hypertension
- 2. uncontrolled diabetes
- 3. current serious cerebrovascular and cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exract of Gelidium elegansExract of Gelidium elegans will be given to the test group. | Dietary supplement | Test group |
| PlaceboPlacebo supplement will be given to the test group. | Dietary supplement | Control group |
Primary outcome
change in body fat mass by DEXA after 12-week treatment
Time frame: 12 week
change in visceral, subcutaneous, total fat area and ratio of visceral and subcutaneous fat area will be combined to report by Fat CT after 12-week treatment
Time frame: 12 week
22 secondary outcomes
change in body weight and body fat mass will be combined to report by Bio-impedance
Time frame: 6 week
change in body weight and body fat mass will be combined to report by Bio-impedance
Time frame: 12 week
change in waist circumference
Time frame: 6 week
change in waist circumference
Time frame: 12 week
change in hip circumference
Time frame: 6 week
change in hip circumference
Time frame: 12 week
change in ratio of waist and hip circumference
Time frame: 6 week
change in ratio of waist and hip circumference
Time frame: 12 week
body mass index
Time frame: 6 week
body mass index
Time frame: 12 week
change in lean body mass by DEXA
Time frame: 6 week
change in lean body mass by DEXA
Time frame: 12 week
change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile
Time frame: 6 week
change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile
Time frame: 12 week
change in laboratory test result of CRP
Time frame: 6 week
change in laboratory test result of CRP
Time frame: 12 week
change in laboratory test result of fasting insulin
Time frame: 6 week
change in laboratory test result of fasting insulin
Time frame: 12 week
change in HOMA-IR
Time frame: 6 week
change in HOMA-IR
Time frame: 12 week
change in HOMA-beta
Time frame: 6 week
change in HOMA-beta
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exract of Gelidium elegans in people with Obesity, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body fat mass by DEXA after 12-week treatment (time frame: 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.