Sensory Stimulation as a Driver of Diet-induced Thermogenesis

N/ANot Yet RecruitingNCT07409025

University Hospital, Basel, Switzerland24 enrolled

Overview

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).

Here, the investigators postulate sensory stimulation (i.e. the sight, smell, auditory and tactile properties, as well as the taste of food) to be drivers of diet induced thermogenesis, an insufficiently understood mechanism of body weight regulation. Research into this area to date has focused on macro-nutrient composition delivered unphysiologically (i.v. or in form of unpalatable solutions). Thereby neglecting the bulk of food-intake associated sensory stimulation and thus the contribution of the brain itself. The investigators aim to gain insight into the role of sensory stimulation in this context by means of a cross-over proof-of concept exploratory clinical trial. Comparing 24 healthy human volunteers receiving a meal bolus with (orally) and without sensory stimulation (nasogastric-tube) by indirect calorimetry, tissue-adjacent temperature measurements and ex vivo analyses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diet-induced Thermogenesis Sensory Function

Interventions

sensory exposurePROCEDURE

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

sensory deprivationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy volunteers of any gender * BMI between 18-25 kg/m2 * age between 18 and 40 years Exclusion Criteria: * 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

Locations (1)

University Hospital Basel, Department of Endocrinology

Basel, Switzerland

Outcomes

Primary Outcomes

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)

Time frame: 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

Skin temperature

brown adipose tissue activity as measured by supraclavicular skin temperature in response to both trial conditions It will be measured using wireless temperature sensors (iButton Thermochron) attached to the skin at 11 pre-defined locations

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

Central Contacts

Matthias Betz, Prof.

CONTACT

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

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

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.