OverweightPhase 3NCT02492698
Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults
A Phase 3 study testing Probiotic group in people with Overweight, run by Yonsei University.
Trial summary
The objective was to evaluate the effect of the consumption of dual probiotic strains containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L. plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Overweight
- What is being tested?
- Probiotic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2015
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 65 years
- Nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL)
- Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2)
Who cannot join
- Constant consumption of any probiotics products within 1 month before screening
- Unstable body weight (body weight change > 1 kg within 3 months before screening)
- Hypertension
- Type 2 diabetes
- Cardiovascular disease
- Cerebrovascular disease
Show all 17Show fewer
- Thyroid disease
- Dietary supplementation within 6 months before screening
- Pregnancy or breast-feeding
- Medication affecting body weight, energy expenditure, glucose control or antibiotic treatment within 3 months before screening
- Acute or chronic infections
- Liver disease
- Kidney disease
- Gastrointestinal disease
- Cancer
- Medication or alcohol abuse
- Any other acute or chronic disease requiring treatment
About this study
The objective was to evaluate the effect of the consumption of dual probiotic strains containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L. plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.
Read the detailed description
A randomized, double-blind, placebo-controlled study was conducted on 120 subjects with age between 20 and 65 years, nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL), and overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2). Over a 12 week test period, the probiotic group consumed 2 g of powder twice a day containing L. curvatus HY7601 and L. plantarum KY1032, while the placebo group consumed the same product without probiotics for 12 weeks.
- Conditions
- Overweight
- Being tested
- Probiotic group, Placebo group
- Keywords
- Probiotic, Weight loss, Lp-PLA2
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic groupDietary supplement
The 2 g of probiotic powder contained 0.1 g of Lactobacillus curvatus HY7601, 0.1 g of Lactobacillus plantarum KY1032, 1.24 g of crystalline cellulose, 0.5 g of lactose, and 0.06 g of blueberry-flavoring agent.
Placebo groupDietary supplement
The 2 g of placebo powder contained 1.34 g of crystalline cellulose, 0.6 g of lactose, and 0.06 g of blueberry-flavoring agent.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | consumed 2 g of powder of a dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032, twice a day after breakfast and dinner. Receives: Dietary Supplement: Probiotic group |
| Placebo group | Placebo comparator | consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
Fat percentage (%)
Measured: 12-week follow-up
Fat mass by DEXA at baseline and 12-week follow-up
Fat mass (g)
Measured: 12-week follow-up
Lean body mass by DEXA at baseline and 12-week follow-up
Lean body mass (g)
Measured: 12-week follow-up
Fat area by computed tomography (CT) at baseline and 12-week follow-up
Fat area (cm2) at levels of 1st lumbar (L1) vertebra and 4th lumbar (L4) vertebra
Measured: 12-week follow-up
Secondary outcomes (5)
Total Cholesterol at baseline and 12-week follow-up
Total Cholesterol (mg/dL)
Measured: 12-week follow-up
HDL Cholesterol at baseline and 12-week follow-up
HDL Cholesterol (mg/dL)
Measured: 12-week follow-up
LDL Cholesterol at baseline and 12-week follow-up
LDL Cholesterol (mg/dL)
Measured: 12-week follow-up
Triglyceride at baseline and 12-week follow-up
Triglyceride (mg/dL)
Measured: 12-week follow-up
High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up
hs-CRP (mg/dL)
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 posted9 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, Ph.D., Principal investigator, Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492698
- Sponsor's protocol ID
- LW_clinical
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults
- ClinicalTrials.gov ID
- NCT02492698
- Acronym / sponsor ID
- LW_clinical
- Conditions
- Overweight
- Keywords
- Probiotic, Weight loss, Lp-PLA2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jul 2015 (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 objective was to evaluate the effect of the consumption of dual probiotic strains containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L. plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.
Detailed description
A randomized, double-blind, placebo-controlled study was conducted on 120 subjects with age between 20 and 65 years, nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL), and overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2). Over a 12 week test period, the probiotic group consumed 2 g of powder twice a day containing L. curvatus HY7601 and L. plantarum KY1032, while the placebo group consumed the same product without probiotics for 12 weeks.
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: Probiotic groupconsumed 2 g of powder of a dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032, twice a day after breakfast and dinner. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupconsumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 65 years
- Nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL)
- Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2)
Key exclusion criteria (17 listed)
- Constant consumption of any probiotics products within 1 month before screening
- Unstable body weight (body weight change > 1 kg within 3 months before screening)
- Hypertension
- Type 2 diabetes
- 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 |
|---|---|---|
| Probiotic groupThe 2 g of probiotic powder contained 0.1 g of Lactobacillus curvatus HY7601, 0.1 g of Lactobacillus plantarum KY1032, 1.24 g of crystalline cellulose, 0.5 g of lactose, and 0.06 g of blueberry-flavoring agent. | Dietary supplement | Probiotic group |
| Placebo groupThe 2 g of placebo powder contained 1.34 g of crystalline cellulose, 0.6 g of lactose, and 0.06 g of blueberry-flavoring agent. | Dietary supplement | Placebo group |
Primary outcome
Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
Time frame: 12-week follow-up
Fat percentage (%)
Fat mass by DEXA at baseline and 12-week follow-up
Time frame: 12-week follow-up
Fat mass (g)
Lean body mass by DEXA at baseline and 12-week follow-up
Time frame: 12-week follow-up
Lean body mass (g)
Fat area by computed tomography (CT) at baseline and 12-week follow-up
Time frame: 12-week follow-up
Fat area (cm2) at levels of 1st lumbar (L1) vertebra and 4th lumbar (L4) vertebra
5 secondary outcomes
Total Cholesterol at baseline and 12-week follow-up
Time frame: 12-week follow-up
HDL Cholesterol at baseline and 12-week follow-up
Time frame: 12-week follow-up
LDL Cholesterol 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
High sensitivity C-reactive protein (hs-CRP) 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 9 Jul 2015.
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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, Ph.D. principal investigator
Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic group in people with Overweight, run by Yonsei University.
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 3 inclusion and 17 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up (time frame: 12-week follow-up). The study lists 4 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 9 Jul 2015.