NCT05313347

Brief Summary

Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.The rewarding effect of sugar will be investigated in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. A gustatory stimulation paradigm designed to induce sensory specific satiety for glucose will be employed. The aim is to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

March 28, 2022

Last Update Submit

November 28, 2023

Conditions

Keywords

fmrisensory specific satiety

Outcome Measures

Primary Outcomes (2)

  • Choice of water compared to choice of sugar during Sensory Specific Satiety.

    Comparing tasting of water with tasting of sugar (G10%) when participants are allowed to freely chose between the two during specific satiety for sugar.

    1 hour

  • Choice of water compared to passive ingestion of 20% sugar solution during Sensory Specific Satiety.

    Comparison of voluntary tasting of water with the "forced" tasting of sugar during specific satiety for sugar.

    1 hour

Secondary Outcomes (1)

  • Influence of variations in BMI on brain activation during Sensory Specific Satiety.

    1 hour

Study Arms (1)

Healty Participants with varying BMI

30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy controls with BMI between 17,5 and 35 kg/m².

You may qualify if:

  • BMI between 17,5 and 35 kg/m².
  • Over age of 18 years.
  • Right-handedness.
  • Normal or corrected-to-normal vision.
  • Capacity to consent.

You may not qualify if:

  • History of head injury or surgery.
  • History of neurological disorder.
  • Severe psychiatric comorbidity.
  • Lifetime or current medical illness that could potentially affect appetite or weight (including eating disorders diagnosis)
  • Smoking.
  • Current psychotropic medication.
  • Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Germany

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • joe simon, Ph.D.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 6, 2022

Study Start

February 1, 2022

Primary Completion

July 1, 2023

Study Completion

October 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations