HealthyNCT03292978
An Intervention on Healthy Adults of Probiotics on Gut Flora Metabolisms of Choline
A study testing probiotics intervention in people with Healthy, run by Huilian Zhu at 1 site in China.
Trial summary
The aim of the study is to examine the effects of probiotics intervention on choline metabolites and intestinal microbiota composition using a randomized double blind clinical trial. Also, we proposed to explore the real-time change of choline metabolites after probiotics intervention through a PC challenge test. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- probiotics intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males at 18 to 30 years old;
- Free from antibiotics and probiotic products for at least 1 month;
- Willing to participate in the study, consume the test product and perform all measurements.
Who cannot join
- Sever physical diseases;
- Intolerance to probiotics or eggs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics Intervention on Gut Flora Metabolisms of Choline:A Randomized Double-Blind Control Trial
The aim of the study is to examine the effects of probiotics intervention on choline metabolites and intestinal microbiota composition using a randomized double blind clinical trial. Also, we proposed to explore the real-time change of choline metabolites after probiotics intervention through a PC challenge test. Our study will clarify the biochemical pathway involved in metabolic diseases and hope to provide a new targeted-preventive and therapeutic strategy for chronic metabolic diseases.
Read the detailed description
Dietary choline (mainly refer to phosphatidylcholine, PC) produce trimethylamine (TMA) through the action of gut flora in vivo. TMA then readily absorbed into systemic circulation and oxidized by hepatic flavin monoxygenases (FMO3) to trimethylamine-N-oxide (TMAO). The elevated levels of circulating TMAO is identified as a risk factor for the prevalence and development of metabolic diseases such as cardiovascular diseases and nonalcoholic fatty liver diseases. Targeting gut flora for reducing TMAO may be a promising approach for preventing chronic metabolic diseases. Recent studies found that some strains representing two different phyla (Firmicutes and Proteobacteria) are capable of producing TMA from choline in vitro. On the other hand, TMA intervention can change the structure of intestinal flora, reducing the abundance of bifidobacterium and lactobacillus. Probiotics can improve the ecological balance of the gut flora, which might be beneficial to human health and disease prevention. However, whether probiotics could inhibit the TMA-producing bacterias and reduce the TMA and TMAO levels through balancing the gut flora was unclear.
In order to explore whether probiotics can reduce the TMA and TMAO levels, we are proposed to recruit 50 volunteers aged from 18-30 years old to participate in the randomized double-blind trial. The volunteers are randomized allocated into different intervention groups. The probiotics intervention group is provided once daily orally-taken powder in a sachet, which contains 4 strains of probiotics. The non-probiotic control is provided with a powder without probiotics , but has same look, color, taste, flavor and weight as the probiotics intervention group. A PC challenge test will be hold before and after the 4 weeks intervention. The blood and fecal sample will be collected before and after the trial and analyzed by appropriate method. The dietary assessment is assessed by a 3-day dietary record.The statistic analysis is by SPSS 23.0.
- Conditions
- Healthy
- Being tested
- probiotics intervention, non-probiotic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics interventionDietary supplement
The probiotics intention is provided with 4 strains of probiotics as a 2g sachet powder, dried with corn starch for 4 weeks.
non-probiotic controlDietary supplement
The placebo is corn starch alone provided and the shape, color, flavor and taste are same with the powder of probiotics intervention.
| Study group | Role | What they receive |
|---|---|---|
| probiotics intervention | Experimental | 1. The probiotic is provided in sachets as a 2g powder dried with corn starch.
2. The powder is orally taken once daily for 4 weeks.
3. The powder contains totally 11 log 10 colony forming units(CFU) of probiotics.
4. The types of probiotics are Lactobacillus.rhamnosus, Lactobacillus.acidophilus, Bifidobacteria.animalis and Bifidobacteria.longum. Receives: Dietary Supplement: probiotics intervention |
| non-probiotic control | Placebo comparator | The placebo is corn starch alone provided and the shape, color, weight,flavor and taste are same with the powder of probiotics intervention. Receives: Dietary Supplement: non-probiotic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
choline metabolites
The metabolites of choline before and after the intervention including free choline, betaine, TMA, TMAO will be measured by UPLC/MS.
Measured: 4 weeks later
Secondary outcomes (3)
intestinal microbiota composition
The intestinal microbiota composition of feces before and after the intervention will be examined by 16S-DNA.
Measured: 4 weeks later
anthropometry measurement
The height and weight which are combined to report BMI in kg/m^2 will be measured before and after the intervention by professional investigators.
Measured: 4 weeks later
blood biochemical markers
Overnight fasting serum total cholesterol (TC), triglyceride (TG), LDL cholesterol (LDLc), HDL cholesterol (HDLc) and fasting blood glucose were measured by colorimetric methods using a Hitachi 7600-010 automated analyzer.
Measured: 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
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 HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huilian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huilian Zhu, Sun Yat-sen University
- Investigators
- Zhu Hui lian, Professor, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292978
- Sponsor's protocol ID
- DIC2016-08
- Status last verified
- Nov 2019
- First submitted
- 19 Sep 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen S, Jiang PP, Yu D, Liao GC, Wu SL, Fang AP, Chen PY, Wang XY, Luo Y, Long JA, Zhong RH, Liu ZY, Li CL, Zhang DM, Zhu HL. Effects of probiotic supplementation on serum trimethylamine-N-oxide level and gut microbiota composition in young males: a double-blinded randomized controlled trial. Eur J Nutr. 2021 Mar;60(2):747-758. doi: 10.1007/s00394-020-02278-1. Epub 2020 May 21.
PubMed 32440731
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Intervention on Gut Flora Metabolisms of Choline:A Randomized Double-Blind Control Trial
- ClinicalTrials.gov ID
- NCT03292978
- Acronym / sponsor ID
- DIC2016-08
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Sep 2017 (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.
The aim of the study is to examine the effects of probiotics intervention on choline metabolites and intestinal microbiota composition using a randomized double blind clinical trial. Also, we proposed to explore the real-time change of choline metabolites after probiotics intervention through a PC challenge test. Our study will clarify the biochemical pathway involved in metabolic diseases and hope to provide a new targeted-preventive and therapeutic strategy for chronic metabolic diseases.
Detailed description
Dietary choline (mainly refer to phosphatidylcholine, PC) produce trimethylamine (TMA) through the action of gut flora in vivo. TMA then readily absorbed into systemic circulation and oxidized by hepatic flavin monoxygenases (FMO3) to trimethylamine-N-oxide (TMAO). The elevated levels of circulating TMAO is identified as a risk factor for the prevalence and development of metabolic diseases such as cardiovascular diseases and nonalcoholic fatty liver diseases. Targeting gut flora for reducing TMAO may be a promising approach for preventing chronic metabolic diseases. Recent studies found that some strains representing two different phyla (Firmicutes and Proteobacteria) are capable of producing TMA from choline in vitro. On the other hand, TMA intervention can change the structure of intestinal flora, reducing the abundance of bifidobacterium and lactobacillus. Probiotics can improve the ecological balance of the gut flora, which might be beneficial to human health and disease prevention. However, whether probiotics could inhibit the TMA-producing bacterias and reduce the TMA and TMAO levels through balancing the gut flora was unclear.
In order to explore whether probiotics can reduce the TMA and TMAO levels, we are proposed to recruit 50 volunteers aged from 18-30 years old to participate in the randomized double-blind trial. The volunteers are randomized allocated into different intervention groups. The probiotics intervention group is provided once daily orally-taken powder in a sachet, which contains 4 strains of probiotics. The non-probiotic control is provided with a powder without probiotics , but has same look, color, taste, flavor and weight as the probiotics intervention group. A PC challenge test will be hold before and after the 4 weeks intervention. The blood and fecal sample will be collected before and after the trial and analyzed by appropriate method. The dietary assessment is assessed by a 3-day dietary record.The statistic analysis is by SPSS 23.0.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics intervention | Experimental | Dietary Supplement: probiotics intervention1. The probiotic is provided in sachets as a 2g powder dried with corn starch. 2. The powder is orally taken once daily for 4 weeks. 3. The powder contains totally 11 log 10 colony forming units(CFU) of probiotics. 4. The types of probiotics are Lactobacillus.rhamnosus, Lactobacillus.acidophilus, Bifidobacteria.animalis and Bifidobacteria.longum. |
| non-probiotic control | Placebo comparator | Dietary Supplement: non-probiotic controlThe placebo is corn starch alone provided and the shape, color, weight,flavor and taste are same with the powder of probiotics intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males at 18 to 30 years old;
- Free from antibiotics and probiotic products for at least 1 month;
- Willing to participate in the study, consume the test product and perform all measurements.
Key exclusion criteria (2 listed)
- Sever physical diseases;
- Intolerance to probiotics or eggs
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 |
|---|---|---|
| probiotics interventionThe probiotics intention is provided with 4 strains of probiotics as a 2g sachet powder, dried with corn starch for 4 weeks. | Dietary supplement | probiotics intervention |
| non-probiotic controlThe placebo is corn starch alone provided and the shape, color, flavor and taste are same with the powder of probiotics intervention. | Dietary supplement | non-probiotic control |
Primary outcome
choline metabolites
Time frame: 4 weeks later
The metabolites of choline before and after the intervention including free choline, betaine, TMA, TMAO will be measured by UPLC/MS.
3 secondary outcomes
intestinal microbiota composition
Time frame: 4 weeks later
anthropometry measurement
Time frame: 4 weeks later
blood biochemical markers
Time frame: 4 weeks later
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 Nov 2019.
- Derived from this study: PubMed 32440731Chen S, Jiang PP, Yu D, Liao GC, Wu SL, Fang AP, Chen PY, Wang XY, Luo Y, Long JA, Zhong RH, Liu ZY, Li CL, Zhang DM, Zhu HL. Effects of probiotic supplementation on serum trimethylamine-N-oxide level and gut microbiota composition in young males: a double-blinded randomized controlled trial. Eur J Nutr. 2021 Mar;60(2):747-758. doi: 10.1007/s00394-020-02278-1. Epub 2020 May 21.
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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.
Zhu Hui lian, Professor study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics intervention in people with Healthy, run by Huilian Zhu at 1 site in China.
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 2 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 Nov 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 China. 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?
choline metabolites (time frame: 4 weeks later). 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 NCT03292978, 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 Nov 2019.