NCT07409025

Brief Summary

This study aims to assess the influence of sensory stimulation on diet-induced energy expenditure by way of a clinical cross-over trial in 24 healthy participants either receiving a meal bolus with (orally) and without sensory stimulation (nasogastric-tube).

Trial Health

63
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Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

January 29, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 29, 2026

Last Update Submit

February 6, 2026

Conditions

Diet-induced ThermogenesisSensory Function

Keywords

Diet-induced thermogenesisSensory Stimulation

Outcome Measures

Primary Outcomes (1)

  • Diet-induced energy expenditure

    diet-induced thermogenesis as determined by indirect calorimetry measurements of VO2 in the sensory exposure condition (full meal) as compared to the sensory deprivation condition (same meal via nasogastric tube)

    data will be collected from baseline (30 minutes before meal bolus administration) up to 300 minutes post-administration, divided into five segments: four 30-minute intervals and one 75-minute interval.

Secondary Outcomes (1)

  • Skin temperature

    data will be collected from baseline (60 minutes before meal bolus administration) up to 300 minutes post-administration

Study Arms (2)

Sensory Exposure

EXPERIMENTAL

Administration of a full meal orally

Procedure: sensory exposure

Sensory Deprivation

EXPERIMENTAL

Administration of the same meal as for the sensory exposure visit by way of a nasogastric tube

Procedure: sensory deprivation

Interventions

sensory exposurePROCEDURE

Administration of a full meal orally ("regular eating") in study visit A

Sensory Exposure
sensory deprivationPROCEDURE

Administration of a full meal via nasogastric tube in study visit B (thereby masking it from the senses)

Sensory Deprivation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers of any gender
  • BMI between 18-25 kg/m2
  • age between 18 and 40 years

You may not qualify if:

  • concomitant medication except for prescription free analgetics (paracetamol, NSAIDs) and oral contraceptives
  • clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
  • allergy to local anaesthetic or any of the study meal ingredients
  • known or suspected non-compliance, drug or alcohol abuse
  • smoker / habitual tobacco use
  • habitual excessive alcohol consumption
  • inability to follow the procedures of the study
  • participation in another study with investigational drug within the 30 days preceding and during the present study
  • previous enrolment into the current study
  • enrolment of the investigator, his/her family members, employees and other dependent persons
  • uncontrolled hypo- or hyperthyroidism
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, 4031, Switzerland

Location

Study Officials

  • Sophia J Wiedemann, Dr. phil. Dr. med. M.Sc.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Betz, Prof.

CONTACT

0041 61 556 56 54Matthias.Betz@usb.ch

Sophia J Wiedemann, Dr. phil. Dr. med. M.Sc.

CONTACT

0041 61 328 44 97sophiajulia.wiedemann@usb.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, cross-over trial in healthy volunteers with random sequence of the two study interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 13, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)