OLFactory Odour Stimulation and FOOD Preferences

Obesity Clinical Trial

— OLFO-FOOD  

Official title:

OLFO-FOOD: OLFactory Odour Stimulation and FOOD Preferences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869110
• Other study ID #: 2023-00511, kt23Timper
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Katharina Timper, Prof. Dr. med.
• Phone: +41 61 328 57 42
• Email: katharina.timper[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Overweight study participants will be included in this study. For the participants the study consists of the screening visit and main visit 1 and 2. In between the main visits there is a wash-out period of 1 week (7 days ± 3 days). In total, participants will have 3 visits. After the screening visit and before the main visit 1, odours will be assigned in a randomized order. Each participant will receive both odours. The two visits (main visit 1 and 2) will have the exact same procedures except for the olfactory odour.

Hunger, appetite, thirst, food perception, nausea, headache and mood will be assessed and the first blood samples will be collected. The participants will receive the aspUraclip® filled with 50 μl of either olfactory stimulation or placebo (propylene glycol), due to the computer-generated randomization order. The "aspUraclip®" will be clipped to the nasal septum for 15 minutes. After olfactory stimulation, vital parameters will be measured and blood samples will be taken. Participants will rate hunger, appetite, thirst, nausea, headache, mood, as well as local nose irritation, odour intensity and odour perception. Directly afterwards, the participants choose food ad libitum from a test-buffet. Participants will have 2 hours to eat from the buffet, but can finish earlier if they wish. Eating time will be recorded. After finishing their meal, vitals will be measured, blood samples will be collected and the participants will rate hunger, appetite (general, carbohydrates, meat, dairy foods, vegetables, fruits, sweets, salty foods), thirst, nausea, headache, mood, food taste, food taste intensity, food scent intensity and food scent perception on a 10-point VAS (visual analogue scale). 2 hours after the start of the test-buffet, patients will rate the same questions on a VAS again, vitals and blood samples will be taken. If the participants eat throughout the 2-hour-timespan of the test-buffet and don't stop early, there will be only one measurement (vitals, VAS, BS) after 2 hours, when the test-buffet ends. Food intake will be measured by weighing the food before and after consumption. Following the test-buffet, patients will have a resting phase of 2 hours. During this phase, patients are free to read, listen to music or similar. After the 2 hour resting phase, vitals will be measured, blood samples collected and VAS-questions asked.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years

• Written informed consent

• BMI =30 kg/m2

• Normosmia (as defined by Sniffin' Sticks Test)

Exclusion Criteria:

• 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

• Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)

• Known liver cirrhosis or other severe liver impairment

• Use of any kind of decongestant more than twice a week

• Uncontrolled dysthyroidism

• Uncontrolled hypertension

• Regular use of psychopharmaceutic drugs

• Study participants aims to start a new diet or exercise program during the study

• Bariatric surgery

• Pregnancy/Lactation

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

• Participation in an interventional study within the last 3 months

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in food preference after olfactory stimulation	Olfactory stimulation compared to placebo in participants with obesity with a BMI =30 kg/m2 assessed by a test-buffet.; Proportion of carbohydrates, fat and protein of the chosen food products (processed foods, warmed-up ready-to-eat meal, fresh fruits and vegetables)	two time assessment at baseline and after 1 week
Secondary	Change of hunger assessed via VAS (Visual Analogue Scale) upon olfactory stimulation	Hunger will be assessed via 10-point VAS Score (0= not at all, 10= maximum)) upon olfactory stimulation compared to placebo before and directly after olfactory stimulation, before and after exposure to a test-buffet.	up to eight time assessment from baseline till day 7
Secondary	Change of appetite assessed via (Visual Analogue Scale) VAS upon olfactory stimulation	Appetite will be assessed via 10-point VAS Score (0= not at all, 10= maximum)) upon olfactory stimulation compared to placebo before and directly after olfactory stimulation, before and after exposure to a test-buffet.	up to eight time assessment from baseline till day 7
Secondary	Change of thirst assessed via (Visual Analogue Scale) VAS upon olfactory stimulation	Thirst will be assessed via 10-point VAS Score (0= not at all, 10= maximum)) upon olfactory stimulation compared to placebo before and directly after olfactory stimulation, before and after exposure to a test-buffet.	up to eight time assessment from baseline till day 7
Secondary	Change of nausea assessed via (Visual Analogue Scale) VAS upon olfactory stimulation	Nausea will be assessed via 10-point VAS Score (0= not at all, 10= maximum)) upon olfactory stimulation compared to placebo before and directly after olfactory stimulation, before and after exposure to a test-buffet.	up to eight time assessment from baseline till day 7
Secondary	Change of headache assessed via (Visual Analogue Scale) VAS upon olfactory stimulation	Headache will be assessed via 10-point VAS Score (0= not at all, 10= maximum)) upon olfactory stimulation compared to placebo before and directly after olfactory stimulation, before and after exposure to a test-buffet.	up to eight time assessment from baseline till day 7
Secondary	Change of mood assessed via (Visual Analogue Scale) VAS upon olfactory stimulation	Mood will be assessed via 10-point VAS Score (0= not at all, 10= maximum)) upon olfactory stimulation compared to placebo before and directly after olfactory stimulation, before and after exposure to a test-buffet.	up to eight time assessment from baseline till day 7
Secondary	Change in plasma glucose Level (mmol/L)	Up to 5 blood samplings will be collected during each main visit, depending on the individual endpoint at the test-buffet: 4 blood samplings (60.8ml) if the participant eats the full 2 hours from the test-buffet, 5 samplings (76ml) if the participant stops eating from the test-buffet early.; Before olfactory stimulation (OS), (Baseline); After OS, before the test-buffet (TB0); After individual endpoint at the test-buffet (TBX); After 2 hours of test-buffet (TB2); After 2 hours of resting phase (TBR)	up to 10 time assessment at visit one (Baseline, TB0, TBX, TB2, TBR) and after 1 week at visit 2 (Baseline TB0, TBX, TB2, TBR)
Secondary	Change in plasma insulin Level (pmol/L)	Up to 5 blood samplings will be collected during each main visit, depending on the individual endpoint at the test-buffet: 4 blood samplings (60.8ml) if the participant eats the full 2 hours from the test-buffet, 5 samplings (76ml) if the participant stops eating from the test-buffet early.; Before OS (Baseline); After OS, before the test-buffet (TB0); After individual endpoint at the test-buffet (TBX); After 2 hours of test-buffet (TB2); After 2 hours of resting phase (TBR)	up to 10 time assessment at visit one (Baseline, TB0, TBX, TB2, TBR) and after 1 week at visit 2 (Baseline TB0, TBX, TB2, TBR)
Secondary	Change in serum cortisol Level (nmol/L)	Up to 5 blood samplings will be collected during each main visit, depending on the individual endpoint at the test-buffet: 4 blood samplings (60.8ml) if the participant eats the full 2 hours from the test-buffet, 5 samplings (76ml) if the participant stops eating from the test-buffet early.; Before OS (Baseline); After OS, before the test-buffet (TB0); After individual endpoint at the test-buffet (TBX); After 2 hours of test-buffet (TB2); After 2 hours of resting phase (TBR)	up to 10 time assessment at visit one (Baseline, TB0, TBX, TB2, TBR) and after 1 week at visit 2 (Baseline TB0, TBX, TB2, TBR)