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Human Gut Microbiota and microRNA Expression

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05392348
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
1.2
Anticipated Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: stachyose
  • Dietary Supplement: Maltodextrin
 N/A

Detailed Description

In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human
Anticipated Study Start Date :
May 25, 2022
Anticipated Primary Completion Date :
Jun 25, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Normal Control group

Subjects with maltodextrin as intervention，5g/kg·bw/day.

Dietary Supplement: Maltodextrin
Maltodextrin is a polysaccharide that is used primarily in foods and beverages as a thickener, sweetener, and/or stabilizer. It is a relatively short-chain polymer (some would call it an oligomer); commercial products contain an average of ≈3 to ≈17 glucose units per chain. It is manufactured by partially hydrolyzing grain starches, usually corn or wheat.
Experimental: Stachyose intervention group

Subjects with stachyose as intervention，5g/kg·bw/day.

Dietary Supplement: stachyose
Stachyose is a tetrasaccharide consisting of sucrose having an alpha-D-galactosyl-(1->6)-alpha-D-galactosyl moiety attached at the 6-position of the glucose.

Outcome Measures

Primary Outcome Measures

  1. expression of microRNA [up to 4 weeks]

    small rna sequencing valuated the microRNA expression in human

  2. structure of gut microbiota [up to 4 weeks]

    16S rDNA sequencing valuated the gut microbiota composition in human

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy human
Exclusion Criteria:
  • people who need intake antibiotics，probiotics or its product

Contacts and Locations

Locations

Site City State Country Postal Code
1 the First Affiliate Hospital of the Air Force Medical University Xi'an Shaanxi China 710062

Sponsors and Collaborators

  • Xijing Hospital

Investigators

  • Study Chair: Chao Guo, Xijing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05392348
Other Study ID Numbers:
  • KY20212094-C-1
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xijing Hospital
stachyose
gut microbiota
microRNA

Study Results

No Results Posted as of May 26, 2022