Human Gut Microbiota and microRNA Expression

Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human

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

Study Overview

• Status: Recruiting
• Conditions: Gut Microbiota; microRNA
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: stachyose

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao Guo; Phone Number: 8203 029-84775475; Email: xysn@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710062
      • Recruiting
      • the First Affiliate Hospital of the Air Force Medical University
      • Contact: Ting Li, PhD; Phone Number: 15891720780; Email: tingli@snnu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy human

Exclusion Criteria:

• people who need intake antibiotics，probiotics or its product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expression of microRNA	small rna sequencing valuated the microRNA expression in human	up to 4 weeks
structure of gut microbiota	16S rDNA sequencing valuated the gut microbiota composition in human	up to 4 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Chao Guo, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2022
• Primary Completion (Anticipated): June 25, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: microRNA; gut microbiota; stachyose
• Other Study ID Numbers: KY20212094-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No