NCT06377956

Brief Summary

The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

April 17, 2024

Last Update Submit

January 19, 2026

Conditions

Keywords

MetabolismMicrobiome/microbiotaBody compositionFood intakeFood preference

Outcome Measures

Primary Outcomes (5)

  • Gut length

    Volunteers will be scanned Magnetic Resonance Imaging(Shanghai united imaging, uMR 790).

    Through study completion for one year, will be measured on arrival.

  • Energy intake

    Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in KJ (kilojoule).

    Through study completion for one year, will be measured on arrival.

  • Fecal energy

    Measuring the heat produced by burning dried feces using an oxygen bomb calorimeter (Parr6400). The total energy per gram tissue will be calculated in kJ (kilojoule)/g.

    Through study completion for one year, will be measured on arrival

  • Microbiome/Microbiota

    Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.

    Through study completion for one year, will be measured on arrival.

  • Metabolites

    Abundance of metabolites will be from metabolomic profiling of feces by LC-MS (liquid chromatography mass spectrometry).

    Through study completion for one year, will be measured on arrival.

Secondary Outcomes (20)

  • Urine energy content

    Through study completion for one year, will be measured on arrival.

  • Body weight

    Through study completion for one year, will be measured on arrival.

  • Waist circumferences

    Through study completion for one year, will be measured on arrival.

  • Height

    Through study completion for one year, will be measured on arrival.

  • Bone mass

    Through study completion for one year, will be measured on arrival.

  • +15 more secondary outcomes

Study Arms (1)

Age between 18-40 years old, 100subjects(50 female and 50 man)

He Shuang(Polyethylene Glycol Electrolytes Powder):1/1.5 sachets of PEG(68.56-102.84g dissolved in water with1/1.5L ) were provided to volunteers based on body weight(BW): BW\<60 kg, 1 sachet , BW≥60 kg, 1.5 sachets, drinking an average of 200/250 mL every 15 minutes. It will cause frequent bowel motions or diarrhoea for a couple of hours afterwards. Raceanisodamine Hydrochloride Injection: intramuscular injection of Raceanisodamine Hydrochloride Injection with 10mg. It may cause dry mouth, red face and blurred vision. The half-life of the medicine is 40 minutes and most of the above symptoms disappear within 1 to 3 hours.

Other: Observation without intervention

Interventions

Observation of gut length, food intake, fecal and urine calories, body composition, microbiota, metabolic rate, metabolomics.

Age between 18-40 years old, 100subjects(50 female and 50 man)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

100 individuals, 50 female and 50 male

You may qualify if:

  • Age between 18-40 years old, healthy and disease free.
  • Regular bowel movements.

You may not qualify if:

  • Individuals who are constipated or suffer from intestinal disorders;
  • Individuals with mental illnesses such as depression and claustrophobia;
  • Individuals with glaucoma and prostate hypertrophy;
  • Metal implants in the body;
  • Pregnant and lactating women;
  • Individuals with blood phobia, pathologic hypotension or hypertension;
  • Use of antibiotics, probiotics, oral laxatives within 8 weeks;
  • Individuals with metabolic diseases (e.g., chronic diseases such as diabetes mellitus); recent weight loss due to various medical reasons;
  • Individuals with infectious diseases (e.g. HIV);
  • Irregular diet, lifestyle, addiction to tobacco, alcohol or drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institute of Advanced Technology

Shenzhen, Guangdong, 518055, China

Location

MeSH Terms

Conditions

Food PreferencesMetabolic Syndrome

Interventions

ObservationMethods

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • John R Speakman, PhD

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, chief researcher

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

May 15, 2024

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations