Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants

Overweight Clinical Trial

Official title:

Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants: a Randomized, Double-blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869799
• Other study ID #: 24 Vigiis 101
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: SunWay Biotech Co., LTD.
• Contact: Sean Lin
• Phone: 02-27929568
• Email: sean.lin[@]sunway.cc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)

Description:

Subjects meeting the inclusion criteria were randomly assigned to 2 groups (Vigiis 101 lactic acid bacteria: n = 50, placebo: n = 50) in a 1:1 ratio, Block : 4 randomization. Randomization was performed by a research statistician not directly involved in the trial. Researchers and subjects were unaware of treatment groups until data analysis was complete.

During the 12-week use trial, subjects were asked to take Vigiis 101 Lactobacillus capsules or a placebo once a day before breakfast. The subjects were required to maintain a regular lifestyle and recorded daily Vigiis 101 Lactobacillus or placebo consumption, diet and the number of steps walked as a measure of physical activity. Body composition, anthropometric and biochemical measurements were measured at weeks 0, 4, 8, and 12 after consumption initiation. Clinical exams are done every 4 weeks in the hospital. Subjects filled out daily diaries that included questions about study product intake, other food intake, number of bowel movements, stool quality (consistency and color), any medications received, and any uncomfortable symptoms such as diarrhea, constipation, Vomiting, flatulence, discomfort, etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects are 20-65-year-old men or non-pregnant women (women of childbearing age are not allowed to become pregnant or breastfeed during the study) and adult volunteers who are conscious and able to communicate.

2. Subjects with a body mass index (BMI) between 23 and 29.9 (kg/m2 ) and classified as overweight according to the World Health Organization Asia-Pacific criteria.

3. Subjects who agree to participate in this trial and voluntarily agree to the test consent in writing.

Exclusion Criteria:

1. Subjects who are pregnant or lactating or expecting pregnancy.

2. Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery.

3. Subjects suffering from high blood pressure (=160/100 mmHg, after resting for 10 minutes) or taking diuretics.

4. Subjects with diabetes (fasting blood glucose (=125 mg/dL).

5. Suffering from heart disease, liver and kidney insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumor or any other diseases that affect the research results.

6. Suffering from depression, schizophrenia, alcoholism, drug addiction and other mental disorders or taking drugs (such as psychotropic drugs, ß receptor blockers).

7. Subjects have taken drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional foods within 2 weeks before the screening visit.

8. Subjects judged to be unable to exercise due to severe musculoskeletal diseases.

9. Subjects who consumed probiotics or expected to consume probiotics within 2 weeks before the screening visit.

10. Subjects who have participated in or are expected to participate in clinical trials within 4 weeks before the screening visit.

The withdrawal criteria are as follows:

(1) Unable to take the test sample on time (i.e. more than 7 days out of every 4 weeks without taking the sample) (2) Unable to cooperate with the return visit on time (after being contacted or lost contact, 7 days beyond the expected return visit time) (2) If the subject chooses to voluntarily stop participating due to personal reasons.

(3) Serious violations of the research protocol. (4) Taking drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional health food with probiotics in the experiment.

(5) When severe adverse reactions occur clinically. (6) The aforementioned "subject exclusion conditions" did not occur during the screening period, and must be withdrawn if they occur during the trial.

(7) Other situations where continuing to participate in the research will endanger the health of the subject. When there is important new information during the execution of the trial (referring to your rights or affecting your willingness to continue participating), you will be notified and further explained. Please reconsider whether to continue participating. You can decide freely and will not cause any discomfort. Or affect their future physicians to your medical care.

(8) The project host or the sponsor may also suspend the entire experiment if necessary.

Related Conditions & MeSH terms

• Body Fat
• Body Weight
• Overweight

Intervention

Dietary Supplement:
• Vigiis 101 Lactobacillus Capsules
Product ingredients: microcrystalline cellulose, corn starch, NTU 101 lactic acid bacteria powder (1.0 x 10^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
• Placebo Capsules
Maltodextrin was used as a placebo

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
SunWay Biotech Co., LTD.

Country where clinical trial is conducted

Taiwan, 

References & Publications (14)

Breton J, Galmiche M, Dechelotte P. Dysbiotic Gut Bacteria in Obesity: An Overview of the Metabolic Mechanisms and Therapeutic Perspectives of Next-Generation Probiotics. Microorganisms. 2022 Feb 16;10(2):452. doi: 10.3390/microorganisms10020452. — View Citation

Cheng MC, Tsai TY, Pan TM. Anti-obesity activity of the water extract of Lactobacillus paracasei subsp. paracasei NTU 101 fermented soy milk products. Food Funct. 2015 Nov;6(11):3522-30. doi: 10.1039/c5fo00531k. Epub 2015 Aug 24. — View Citation

Chiang SS, Pan TM. Antiosteoporotic effects of Lactobacillus -fermented soy skim milk on bone mineral density and the microstructure of femoral bone in ovariectomized mice. J Agric Food Chem. 2011 Jul 27;59(14):7734-42. doi: 10.1021/jf2013716. Epub 2011 J — View Citation

Chiu CH, Lu TY, Tseng YY, Pan TM. The effects of Lactobacillus-fermented milk on lipid metabolism in hamsters fed on high-cholesterol diet. Appl Microbiol Biotechnol. 2006 Jun;71(2):238-45. doi: 10.1007/s00253-005-0145-0. Epub 2005 Sep 20. — View Citation

Leon Aguilera XE, Manzano A, Pirela D, Bermudez V. Probiotics and Gut Microbiota in Obesity: Myths and Realities of a New Health Revolution. J Pers Med. 2022 Aug 4;12(8):1282. doi: 10.3390/jpm12081282. — View Citation

Liu CF, Tung YT, Wu CL, Lee BH, Hsu WH, Pan TM. Antihypertensive effects of Lactobacillus-fermented milk orally administered to spontaneously hypertensive rats. J Agric Food Chem. 2011 May 11;59(9):4537-43. doi: 10.1021/jf104985v. Epub 2011 Apr 4. — View Citation

Liu TH, Tsai TY, Pan TM. The Anti-Periodontitis Effects of Ethanol Extract Prepared Using Lactobacillus paracasei subsp. paracasei NTU 101. Nutrients. 2018 Apr 12;10(4):472. doi: 10.3390/nu10040472. — View Citation

Musazadeh V, Zarezadeh M, Ghalichi F, Ahrabi SS, Jamilian P, Jamilian P, Ghoreishi Z. Anti-obesity properties of probiotics; a considerable medical nutrition intervention: Findings from an umbrella meta-analysis. Eur J Pharmacol. 2022 Aug 5;928:175069. do — View Citation

Nam GE, Kim YH, Han K, Jung JH, Rhee EJ, Lee WY; Obesity Fact Sheet of the Korean Society for the Study of Obesity. Obesity Fact Sheet in Korea, 2020: Prevalence of Obesity by Obesity Class from 2009 to 2018. J Obes Metab Syndr. 2021 Jun 30;30(2):141-148. — View Citation

Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgar — View Citation

Tsai TY, Chu LH, Lee CL, Pan TM. Atherosclerosis-preventing activity of lactic acid bacteria-fermented milk-soymilk supplemented with Momordica charantia. J Agric Food Chem. 2009 Mar 11;57(5):2065-71. doi: 10.1021/jf802936c. — View Citation

Tsai YT, Cheng PC, Fan CK, Pan TM. Time-dependent persistence of enhanced immune response by a potential probiotic strain Lactobacillus paracasei subsp. paracasei NTU 101. Int J Food Microbiol. 2008 Dec 10;128(2):219-25. doi: 10.1016/j.ijfoodmicro.2008.08 — View Citation

Tsai YT, Cheng PC, Pan TM. Immunomodulating activity of Lactobacillus paracasei subsp. paracasei NTU 101 in enterohemorrhagic Escherichia coli O157H7-infected mice. J Agric Food Chem. 2010 Nov 10;58(21):11265-72. doi: 10.1021/jf103011z. Epub 2010 Oct 13. — View Citation

Vallianou N, Dalamaga M, Stratigou T, Karampela I, Tsigalou C. Do Antibiotics Cause Obesity Through Long-term Alterations in the Gut Microbiome? A Review of Current Evidence. Curr Obes Rep. 2021 Sep;10(3):244-262. doi: 10.1007/s13679-021-00438-w. Epub 202 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI improvement	Improvement in BMI from baseline was used as the primary outcome.	12 weeks
Secondary	Other body index improvements	The secondary outcome was the improvement in body fat percentage (measured in %).	12 weeks