University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT05869110
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: two time assessment at baseline and after 1 week
Olfactory stimulation compared to placebo in participants with obesity with a BMI ≥30 kg/m2 assessed by a test-buffet.
Time frame: two time assessment at baseline and after 1 week
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)
Time frame: up to eight time assessment from baseline till day 7
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.
Time frame: up to eight time assessment from baseline till day 7
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.
Time frame: up to eight time assessment from baseline till day 7
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.
Time frame: up to eight time assessment from baseline till day 7
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.
Time frame: up to eight time assessment from baseline till day 7
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.
Time frame: up to eight time assessment from baseline till day 7
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
University Hospital, Basel, Switzerland
Other
OLFO-FOOD: OLFactory Odour Stimulation and FOOD Preferences
Acronym: OLFO-FOOD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05742165
Behavior, Body Weight
New York, United States
View Trial DetailsNCT05882045
Body Weight, Cardiovascular Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT00342732
Body Weight, Nutrition Disorders
Phoenix, Arizona, United States
View Trial Details