ObesityTRELONCT06423287
Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals
A study testing Lactobacillus plantarum LP-KFY04 in people with Obesity, run by Zhujiang Hospital at 1 site in China.
Trial summary
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lactobacillus plantarum LP-KFY04
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 to 65 years old
- BMI 24.0 to 40kg/m2
- Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)
Who cannot join
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 or type 2 diabetes and prescribing hypoglycemic therapy
- History of malignant tumors
- Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2)
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction, or stroke) within the past 6 months
- History of serious gastrointestinal disease or gastrointestinal surgery within the past 12 months
Show all 14Show fewer
- History of Cushing's syndrome, hypothyroidism, acromegaly, and hypothalamic obesity
- Smoking or have smoked within the past 3 months of the screening period
- Drinking alcohol or drinking more than 15 grams of alcohol per day within the past 3 months of the screening period
- Taking any medicine that may affect weight or metabolism within the past 6 months, including weight loss medications, antipsychotics, or other medications identified by the researchers
- Currently involving in a weight loss program or having significant weight change within the past 3 months (> 5% of current weight)
- Women who are pregnant or planning for pregnant
- Patients who are unable to complete 12-week follow-up (due to health conditions or immigration reasons)
- Patients who are unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.
Read the detailed description
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks'trial.Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial.
- Conditions
- Obesity
- Being tested
- Lactobacillus plantarum LP-KFY04, Take placebo in addition to the limited diet.
- Keywords
- Obesity, Time-restricted Diet, Probiotic Compound LP-KFY04, Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum LP-KFY04Dietary supplement
Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks' trial.
Take placebo in addition to the limited diet.Other
Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks'trial.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum LP-KFY04 | Experimental | Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks' trial. Receives: Dietary Supplement: Lactobacillus plantarum LP-KFY04 |
| placebo | Placebo comparator | Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial. Receives: Other: Take placebo in addition to the limited diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body weight from baseline to 12 weeks after intervention
Measured: 12 weeks
Secondary outcomes (11)
Changes of BMI compared with baseline in subjects
Measured: 12 weeks
Changes of waist circumference compared with baseline in subjects
Measured: 12 weeks
Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA)
Measured: 12 weeks
Change of subjects' HOMA-IR compared with baseline
Measured: 12 weeks
Changes of blood pressure in subjects compared with baseline
Measured: 12 weeks
Changes of blood glucose in subjects compared with baseline
Measured: 12 weeks
Changes of blood lipids in subjects compared with baseline
Blood lipids includes total cholesterol、triglyceride、LDL-c、HDL-c.
Measured: 12 weeks
Changes of intestinal microbial composition compared with baseline in subjects
Species of intestinal microbial includes Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria.
Measured: 12 weeks
Changes of intestinal microbial abundance compared with baseline in subjects
Proportion of intestinal microbial such as Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria
Measured: 12 weeks
Changes of plasma metabolite compared with baseline in subjects
Plasma metabolite includes arachidonic acid 、betaine、glutathione and so on.
Measured: 12 weeks
The incidence of adverse events in two groups of subjects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Apr 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
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 Zhujiang HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Chen, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423287
- Sponsor's protocol ID
- 2024LX0016_GY
- Acronym
- TRELO
- Status last verified
- Mar 2024
- First submitted
- 15 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06423287
- Acronym / sponsor ID
- TRELO / 2024LX0016_GY
- Conditions
- Obesity
- Keywords
- Obesity, Time-restricted Diet, Probiotic Compound LP-KFY04, Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 21 May 2024 (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.
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.
Detailed description
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks'trial.Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum LP-KFY04 | Experimental | Dietary Supplement: Lactobacillus plantarum LP-KFY04Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks' trial. |
| placebo | Placebo comparator | Other: Take placebo in addition to the limited diet.Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18 to 65 years old
- BMI 24.0 to 40kg/m2
- Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)
Key exclusion criteria (14 listed)
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 or type 2 diabetes and prescribing hypoglycemic therapy
- History of malignant tumors
- Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2)
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction, or stroke) within the past 6 months
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 |
|---|---|---|
| Lactobacillus plantarum LP-KFY04Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks' trial. | Dietary supplement | Lactobacillus plantarum LP-KFY04 |
| Take placebo in addition to the limited diet.Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks'trial. | Other | placebo |
Primary outcome
Change of body weight from baseline to 12 weeks after intervention
Time frame: 12 weeks
11 secondary outcomes
Changes of BMI compared with baseline in subjects
Time frame: 12 weeks
Changes of waist circumference compared with baseline in subjects
Time frame: 12 weeks
Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame: 12 weeks
Change of subjects' HOMA-IR compared with baseline
Time frame: 12 weeks
Changes of blood pressure in subjects compared with baseline
Time frame: 12 weeks
Changes of blood glucose in subjects compared with baseline
Time frame: 12 weeks
Changes of blood lipids in subjects compared with baseline
Time frame: 12 weeks
Changes of intestinal microbial composition compared with baseline in subjects
Time frame: 12 weeks
Changes of intestinal microbial abundance compared with baseline in subjects
Time frame: 12 weeks
Changes of plasma metabolite compared with baseline in subjects
Time frame: 12 weeks
The incidence of adverse events in two groups of subjects
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Hong Chen, MD principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum LP-KFY04 in people with Obesity, run by Zhujiang Hospital 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 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Chen, MD (13602759769, rubychq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body weight from baseline to 12 weeks after intervention (time frame: 12 weeks). 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 21 May 2024.