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ObesityNCT04980599

Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study

A study testing probiotic drink with Lactobacillus paracasei K56, maltodextrin and Probiotic powder E3 in people with Obesity and Adiposity, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Adiposity
What is being tested?
probiotic drink with Lactobacillus paracasei K56, maltodextrin and Probiotic powder E3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteChina
Study dates
10 Jan 2021to 31 Dec 2021
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI>=30kg/m2,or percent of body fat(PBF) >=25% for male, >=30 for female.
  • Age: 18 - 60 years old adults

Who cannot join

  • patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome
  • History of intervention with fat-reducing drugs or health products in the past 2 months
  • take weight control measures (diet, exercise, etc.) within the past month
  • Those who cannot guarantee to maintain their current lifestyle during the trial period
  • Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hua Dong Hospital Affiliated to Fu Dan University

    Shanghai

Other trials in China

About this study

Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.

In this before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.

Conditions
Obesity, Adiposity
Being tested
probiotic drink with Lactobacillus paracasei K56, maltodextrin, Probiotic powder E3, Probiotic powder E5, probiotic capsule E7
Keywords
obesity, lactobacillus paracasei, body fat, visceral fat area
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • probiotic drink with Lactobacillus paracasei K56Dietary supplement

    Probiotic drink (K56 10^11CFU) 350ml/d for 60days

  • maltodextrinDietary supplement

    maltodextrin ,for 60days

  • Probiotic powder E3Dietary supplement

    Probiotic powder 3.0g/d (K56 10^10cfu) 60days;

  • Probiotic powder E5Dietary supplement

    probiotic powder 8g/day for 60days

  • probiotic capsule E7Dietary supplement

    probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days

  • probiotic capsule E9Dietary supplement

    probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days

  • probiotic capsule E10Dietary supplement

    probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days

  • probiotic capsule E11Dietary supplement

    probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days

Study groups in NCT04980599
Study groupRoleWhat they receive
K56 very high dose -E1Active comparatorProbiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days
Receives: Dietary Supplement: probiotic drink with Lactobacillus paracasei K56
control -E2Placebo comparatormaltodextrin , for 60days
Receives: Dietary Supplement: maltodextrin
K56 high dose-E3Active comparatorProbiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days
Receives: Dietary Supplement: Probiotic powder E3
K56 middle dose-E5Active comparatorProbiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days
Receives: Dietary Supplement: Probiotic powder E5
K56 low dose -E7Active comparatorprobiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days
Receives: Dietary Supplement: probiotic capsule E7
K56 middle dose-E9Active comparatorprobiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days
Receives: Dietary Supplement: probiotic capsule E9
K56 high dose-E1KActive comparatorprobiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days
Receives: Dietary Supplement: probiotic capsule E10
K56 very high dose-E11Active comparatorprobiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days
Receives: Dietary Supplement: probiotic capsule E11

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percent body fat

    percent body fat (%) will be assessed at baseline and after 60days of intervention

    Measured: 60days

  2. visceral fat area

    visceral fat area (cm^2) will be assessed at baseline and after 60days of intervention

    Measured: 60days

Secondary outcomes (8)

  1. Serum Lipid Profile

    Serum total cholesterol(mmol/L)，Serum triglycerides(mmol/L)，Low-density lipoprotein(mmol/L)，High density lipoprotein(mmol/L) will be measured at baseline and after 60days of intervention

    Measured: 60 days

  2. fasting blood glucose

    fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention

    Measured: 60 days

  3. Glycated hemoglobin

    Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention

    Measured: 60 days

  4. Glycosylated albumin

    Glycosylated albumin(%) will be measured at baseline and after 60days of intervention

    Measured: 60 days

  5. skeletal muscle mass

    skeletal muscle mass (kg) will be assessed at baseline and after 60days of intervention

    Measured: 60 days

  6. waist to hip ratio (WHR)

    waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention

    Measured: 60 days

  7. Body Mass Index BMI

    Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention

    Measured: 60 days

  8. body weight

    Body weight (kg) will be assessed at baseline and after 60days of intervention

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start10 Jan 2021
  3. Primary completion30 Aug 2021
  4. Study completion31 Dec 2021

Resources

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
Single blind
Who is masked
Participant
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04980599
Sponsor's protocol ID
ZBao
Status last verified
Jul 2021
First submitted
8 Jul 2021
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kadeer G, Fu W, He Y, Feng Y, Liu WH, Hung WL, Feng H, Zhao W. Effect of different doses of Lacticaseibacillus paracasei K56 on body fat and metabolic parameters in adult individuals with obesity: a pilot study. Nutr Metab (Lond). 2023 Mar 21;20(1):16. doi: 10.1186/s12986-023-00739-y.

    PubMed 36944956

Questions about this trial

What is this clinical trial studying?

A study testing probiotic drink with Lactobacillus paracasei K56, maltodextrin and Probiotic powder E3 in people with Obesity and Adiposity, run by Fudan University 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 2 inclusion and 5 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 10 Jan 2023. 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?

percent body fat (time frame: 60days). 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?

On the ClinicalTrials.gov record for NCT04980599, 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 10 Jan 2023.

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