NCT05392348

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 26, 2022

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

July 7, 2021

Last Update Submit

May 24, 2022

Conditions

Gut MicrobiotamicroRNA

Keywords

stachyosegut microbiotamicroRNA

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Normal Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Stachyose intervention group

EXPERIMENTAL

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

Dietary Supplement: stachyose

Interventions

stachyoseDIETARY_SUPPLEMENT

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.

Stachyose intervention group
MaltodextrinDIETARY_SUPPLEMENT

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.

Normal Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy human

You may not qualify if:

  • people who need intake antibiotics，probiotics or its product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliate Hospital of the Air Force Medical University

Xi'an, Shaanxi, 710062, China

RECRUITING

MeSH Terms

Interventions

stachyosemaltodextrin

Study Officials

  • Chao Guo

    Xijing Hospital

    STUDY CHAIR

Central Study Contacts

Chao Guo

CONTACT

029-84775475xysn@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

May 26, 2022

Study Start

May 25, 2022

Primary Completion

June 25, 2022

Study Completion

June 30, 2022

Last Updated

May 26, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)