HypertriglyceridemiaPhase 3NCT02215694
Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels
A Phase 3 study testing dual probiotics in people with Hypertriglyceridemia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V. Read more about this study
- Who is it for?
- Ages 24 to 68 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- dual probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Mar 2014
- Phase
- Phase 3
- 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 24 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nondiabetic (plasma fasting glucose, <126mg/dL; 2-hour plasma glucose, <200mg/dL)
- borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)
Who cannot join
- lipid-lowering medications use
- any medications or supplement use
- any probiotics products use for the past 1 months
- dyslipidemia
- diabetes mellitus
- hypertension
Show all 14Show fewer
- liver disease
- renal disease
- cardiovascular disease
- cerebrovascular disease
- pancreatitis
- cancer
- medication or alcohol abuse
- pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics
Seoul, 120-749
About this study
Official title: Supplementation of Dual Probiotic Strains, Lactobacillus Curvatus HY7601 and Lactobacillus Plantarum KY1032, Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels in Nondiabetic and Hypertriglyceridemic Subjects
The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V.
Read the detailed description
A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test period, the probiotic group consumed 2g of powder daily containing dual probiotic strains, while the placebo group consumed the same without probiotics.
- Conditions
- Hypertriglyceridemia
- Being tested
- dual probiotics, placebo
- Keywords
- Apolipoprotein A-V, LDL particle size, probiotic, triglyceride
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual probioticsDietary supplement
Also called probiotic
2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
placeboDietary supplement
2g of powder daily without probiotics
| Study group | Role | What they receive |
|---|---|---|
| probiotic group | Experimental | consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032) Receives: Dietary Supplement: dual probiotics |
| placebo group | Placebo comparator | consumed 2g of powder daily without probiotics Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ApoA5-1131 genotype
ApoA5-1131 T>C
Measured: at baseline
Secondary outcomes (6)
Fasting glucose at baseline and 12-week follow-up
Serum fasting glucose (mg/dL)
Measured: 12-week follow-up
Insulin at baseline and 12-week follow-up
Serum insulin (μIU/dL)
Measured: 12-week follow-up
C-peptide at baseline and 12-week follow-up
Serum C-peptide (μEq/L)
Measured: 12-week follow-up
Apolipoprotein A-V at baseline and 12-week follow-up
Plasma apolipoprotein A-V (ng/mL)
Measured: 12-week follow-up
Triglyceride at baseline and 12-week follow-up
Serum triglyceride (mg/dL)
Measured: 12-week follow-up
Free fatty acid at baseline and 12-week follow-up
Serum free fatty acid (μEq/L)
Measured: 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215694
- Sponsor's protocol ID
- probiotics_140801
- Status last verified
- Aug 2014
- First submitted
- 2 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahn HY, Kim M, Ahn YT, Sim JH, Choi ID, Lee SH, Lee JH. The triglyceride-lowering effect of supplementation with dual probiotic strains, Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032: Reduction of fasting plasma lysophosphatidylcholines in nondiabetic and hypertriglyceridemic subjects. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):724-33. doi: 10.1016/j.numecd.2015.05.002. Epub 2015 May 14.
PubMed 26044516
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Dual Probiotic Strains, Lactobacillus Curvatus HY7601 and Lactobacillus Plantarum KY1032, Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels in Nondiabetic and Hypertriglyceridemic Subjects
- ClinicalTrials.gov ID
- NCT02215694
- Acronym / sponsor ID
- probiotics_140801
- Conditions
- Hypertriglyceridemia
- Keywords
- Apolipoprotein A-V, LDL particle size, probiotic, triglyceride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Aug 2014 (estimated)
- 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.
The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V.
Detailed description
A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test period, the probiotic group consumed 2g of powder daily containing dual probiotic strains, while the placebo group consumed the same without probiotics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Experimental | Dietary Supplement: dual probioticsconsumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032) |
| placebo group | Placebo comparator | Dietary Supplement: placeboconsumed 2g of powder daily without probiotics |
Who may qualify
- Ages
- 24 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nondiabetic (plasma fasting glucose, <126mg/dL; 2-hour plasma glucose, <200mg/dL)
- borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)
Key exclusion criteria (14 listed)
- lipid-lowering medications use
- any medications or supplement use
- any probiotics products use for the past 1 months
- dyslipidemia
- diabetes mellitus
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 |
|---|---|---|
| dual probioticsAlso: probiotic2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032) | Dietary supplement | probiotic group |
| placebo2g of powder daily without probiotics | Dietary supplement | placebo group |
Primary outcome
ApoA5-1131 genotype
Time frame: at baseline
ApoA5-1131 T>C
6 secondary outcomes
Fasting glucose at baseline and 12-week follow-up
Time frame: 12-week follow-up
Insulin at baseline and 12-week follow-up
Time frame: 12-week follow-up
C-peptide at baseline and 12-week follow-up
Time frame: 12-week follow-up
Apolipoprotein A-V at baseline and 12-week follow-up
Time frame: 12-week follow-up
Triglyceride at baseline and 12-week follow-up
Time frame: 12-week follow-up
Free fatty acid at baseline and 12-week follow-up
Time frame: 12-week follow-up
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 13 Aug 2014.
- Derived from this study: PubMed 26044516Ahn HY, Kim M, Ahn YT, Sim JH, Choi ID, Lee SH, Lee JH. The triglyceride-lowering effect of supplementation with dual probiotic strains, Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032: Reduction of fasting plasma lysophosphatidylcholines in nondiabetic and hypertriglyceridemic subjects. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):724-33. doi: 10.1016/j.numecd.2015.05.002. Epub 2015 May 14.
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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.
Jong Ho Lee, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dual probiotics in people with Hypertriglyceridemia, 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 14 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 13 Aug 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ApoA5-1131 genotype (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215694, which also lists 1 linked publication.
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 13 Aug 2014.