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

NCT05869799 | Unknown

• 1 other identifier: 24 Vigiis 101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Body Weight; Body Fat; Overweight

Outcome Measures

Primary Outcomes (1)

• BMI improvement

  Improvement in BMI from baseline was used as the primary outcome.

  12 weeks

Secondary Outcomes (1)

• Other body index improvements

  12 weeks

Study Arms (2)

Vigiis 101 Lactobacillus Capsules

EXPERIMENTAL

Vigiis 101 Lactic Acid Bacteria Capsules is a commercially available product for Lactobacillus paracasei subspecies paracasei NTU 101 (NTU 101) is a strain of Lactobacillus isolated from the intestinal tract of newborns in Taiwan. 10 billion CFU/cap of NTU 101 freeze-dried powder (production research and development: Chenhui Biotechnology Co., Ltd. Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in vegetable capsules were prepared.

Dietary Supplement: Vigiis 101 Lactobacillus Capsules

Placebo Capsules

PLACEBO COMPARATOR

Maltodextrin was used as a placebo.

Dietary Supplement: Placebo Capsules

Interventions

Vigiis 101 Lactobacillus Capsules DIETARY_SUPPLEMENT

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.

Vigiis 101 Lactobacillus Capsules

Placebo Capsules DIETARY_SUPPLEMENT

Maltodextrin was used as a placebo

Placebo Capsules

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who are pregnant or lactating or expecting pregnancy.
• Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery.
• Subjects suffering from high blood pressure (≥160/100 mmHg, after resting for 10 minutes) or taking diuretics.
• Subjects with diabetes (fasting blood glucose (≥125 mg/dL).
• 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.
• Suffering from depression, schizophrenia, alcoholism, drug addiction and other mental disorders or taking drugs (such as psychotropic drugs, β receptor blockers).
• 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.
• Subjects judged to be unable to exercise due to severe musculoskeletal diseases.
• Subjects who consumed probiotics or expected to consume probiotics within 2 weeks before the screening visit.
• 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.
• (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.

Sponsors & Collaborators

• SunWay Biotech Co., LTD.: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114202, Taiwan

RECRUITING

Related 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.

  PMID: 35208906 RESULT

• 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 Jun 21.

  PMID: 21668014 RESULT

• 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.

  PMID: 16172889 RESULT

• 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.

  PMID: 26299532 RESULT

• 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.

  PMID: 36013231 RESULT

• 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.

  PMID: 21446645 RESULT

• 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.

  PMID: 29649103 RESULT

• 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. doi: 10.1016/j.ejphar.2022.175069. Epub 2022 Jun 1.

  PMID: 35659967 RESULT

• 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. doi: 10.7570/jomes21056.

  PMID: 34158420 RESULT

• 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, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.

  PMID: 24009397 RESULT

• 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.

  PMID: 19216552 RESULT

• 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.

  PMID: 20942489 RESULT

• 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.2008.08.009. Epub 2008 Aug 26.

  PMID: 18809220 RESULT

• 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 2021 May 4.

  PMID: 33945146 RESULT

MeSH Terms

Conditions

Body Weight; Overweight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• WEN-HUI FANG, Ph. D.

  Chief of Family medicine department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Lin

CONTACT

02-27929568; sean.lin@sunway.cc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This experiment adopts a block random assignment design, and the system assignment table (Block randomization, block size = 6) randomly generated by the program is given serial numbers and assigned to groups. The probability of assignment to each group is 1/2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)