NCT05869110

Brief Summary

The aim of the present "OLFO-FOOD" clinical trial is to investigate, if olfactory stimulation impacts food choice, reference and calorie intake in humans with obesity assessed using a test buffet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 20, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

May 11, 2023

Last Update Submit

December 6, 2024

Conditions

Obesity

Keywords

olfactory stimulationHungerAppetitecalorie intakefood choicemetabolic parameters

Outcome Measures

Primary Outcomes (1)

  • Change in calorie intake after olfactory stimulation

    Olfactory stimulation compared to placebo in participants with obesity with a BMI ≥30 kg/m2 assessed by a test-buffet.

    two time assessment at baseline and after 1 week

Secondary Outcomes (10)

  • Change in food preference after olfactory stimulation

    two time assessment at baseline and after 1 week

  • Change of hunger assessed via VAS (Visual Analogue Scale) upon olfactory stimulation

    up to eight time assessment from baseline till day 7

  • Change of appetite assessed via (Visual Analogue Scale) VAS upon olfactory stimulation

    up to eight time assessment from baseline till day 7

  • Change of thirst assessed via (Visual Analogue Scale) VAS upon olfactory stimulation

    up to eight time assessment from baseline till day 7

  • Change of nausea assessed via (Visual Analogue Scale) VAS upon olfactory stimulation

    up to eight time assessment from baseline till day 7

  • +5 more secondary outcomes

Study Arms (2)

Experimental Intervention

EXPERIMENTAL

Olfactory stimulation

Other: Effects of odours on calorie intake, food choice and metabolic parameters

Placebo

PLACEBO COMPARATOR

Propylene glycol

Other: Effects of odours on calorie intake, food choice and metabolic parameters

Interventions

Effects of odours on calorie intake, food choice and metabolic parametersOTHER

Evaluation of the effects of olfactory stimulation compared to placebo on calorie intake and preference of food during a test-buffet. Odours will be assigned in a randomized order. Each participant will receive both odours, in between there will be a wash-out period of 1 week.

Experimental InterventionPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Written informed consent
  • BMI ≥30 kg/m2
  • Normosmia (as defined by Sniffin' Sticks Test)

You may not qualify if:

  • Known allergy to olfactory stimulation substance, citrus fruits, citrus flavours, citrus food products
  • Lactose-intolerance, celiac disease or non-celiac wheat sensitivity
  • Diet other than omnivore or vegetarian
  • Eating disorder (now or in the past)
  • Dysphagia
  • Acute disease affecting food intake
  • Acute upper respiratory tract infection, acute or chronic sinusitis
  • Severe visual impairment (vision \<10%)
  • Surgical intervention of the nasal cavity or the paranasal sinus
  • Current illicit drug abuse including daily marijuana and CBD (Cannabidiol) consumption (alcohol ≤2 drinks per day allowed)
  • Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
  • Type 1 and 2 diabetes mellitus
  • Treatment with insulin-sensitizing drugs within the last 3 months
  • Treatment with Glucagon-like Peptide 1 (GLP1)-analoga
  • History of neurodegenerative diseases, severe head trauma
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Katharina Timper, Prof. Dr. med.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study participants will not be informed which substances are investigated
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, placebo-controlled, single-blind, cross-over, single-centre trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

April 20, 2023

Primary Completion

July 31, 2024

Study Completion

August 20, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations

CH(1)