An Intervention on Healthy Adults of Probiotics on Gut Flora Metabolisms of Choline

NCT03292978 | Completed

• 1 other identifier: DIC2016-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• choline metabolites

  The metabolites of choline before and after the intervention including free choline, betaine, TMA, TMAO will be measured by UPLC/MS.

  4 weeks later

Secondary Outcomes (3)

• intestinal microbiota composition

  4 weeks later

• anthropometry measurement

  4 weeks later

• blood biochemical markers

  4 weeks later

Study Arms (2)

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.

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.

Dietary Supplement: non-probiotic control

Interventions

probiotics intervention DIETARY_SUPPLEMENT

The probiotics intention is provided with 4 strains of probiotics as a 2g sachet powder, dried with corn starch for 4 weeks.

probiotics intervention

non-probiotic control DIETARY_SUPPLEMENT

The placebo is corn starch alone provided and the shape, color, flavor and taste are same with the powder of probiotics intervention.

non-probiotic control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Sever physical diseases;
• Intolerance to probiotics or eggs

Sponsors & Collaborators

• Huilian Zhu: lead

Study Sites (1)

SunYat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 32440731 DERIVED

Study Officials

• Zhu Hui lian, Professor

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 26, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

CN (1)