NCT05719142

Brief Summary

The overall objective of the research project is to characterize the consequences of digital food stimuli exposure on eating behavior. Specifically, we aim to study cephalic phase physiology, food choice and quantity, as well as post-ingestive sensations in response to viewing sensory-specific food pictures. Furthermore, we want to examine whether these outcomes depend on sweet taste liking, as determined by FGF21 concentrations in the blood and the phenotypical Sweet Taste Liker Test. Section 2.1 lists the primary hypotheses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

January 17, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

January 19, 2023

Last Update Submit

August 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pancreatic polypeptide concentrations (pg/ml)

    Assessed from blood samples in fasted state. Mixed models repeated measures comparison with subsequent post hoc testing.

    Change against baseline (t = -15, 0 minutes) at t = 2, 4, 6, 8, 10, 15, 30 minutes, compared between visits (at least one week between each visit)

Secondary Outcomes (17)

  • Hunger (self-reported, VAS)

    Baseline (t = -15, 0 minutes) vs. after picture viewing (t = 15 minutes) vs. after breakfast consumption (t = 45 minutes), between-visit differences in differences (at least one week between each visit)

  • Desire to eat something (self-reported, VAS)

    Baseline (t = -15, 0 minutes) vs. after picture viewing (t = 15 minutes) vs. after breakfast consumption (t = 45 minutes), between-visit differences in differences (at least one week between each visit)

  • Desire for something sweet (self-reported, VAS)

    Baseline (t = -15, 0 minutes) vs. after picture viewing (t = 15 minutes) vs. after breakfast consumption (t = 45 minutes), between-visit differences in differences (at least one week between each visit)

  • Desire for something salty (self-reported, VAS)

    Baseline (t = -15, 0 minutes) vs. after picture viewing (t = 15 minutes) vs. after breakfast consumption (t = 45 minutes), between-visit differences in differences (at least one week between each visit)

  • Desire for something fatty (self-reported, VAS)

    Baseline (t = -15, 0 minutes) vs. after picture viewing (t = 15 minutes) vs. after breakfast consumption (t = 45 minutes), between-visit differences in differences (at least one week between each visit)

  • +12 more secondary outcomes

Study Arms (3)

Sweet Food (SW)

EXPERIMENTAL

Exposure to pictures of sweet food.

Other: Picture exposure

Savoury Food (SA)

EXPERIMENTAL

Exposure to pictures of savoury food.

Other: Picture exposure

Non-Food (NF)

EXPERIMENTAL

Exposure to pictures of non-food items.

Other: Picture exposure

Interventions

Participants are shown pictures for 15 minutes; 50 images in total, each shown for 6 seconds, and 3 times in total.

Non-Food (NF)Savoury Food (SA)Sweet Food (SW)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal or corrected-to-normal vision and no color-blindness
  • Danish understanding

You may not qualify if:

  • Regular smoking
  • Dietary constraints, e.g., vegan/vegetarian, gluten or lactose intolerance, allergies
  • For women: pregnancy / planned pregnancy (within the study period) / lactating
  • Unable to understand the informed consent and the study procedures
  • Self-reported history of an eating disorder in the past 3 years
  • Uncontrolled medical issues, e.g.including, cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, GI or psychiatric disease, diabetes or other endocrine diseases, immunosuppression
  • Current treatment with medication or medical devices significantly affecting glucose metabolism, appetite, or energy balance
  • Current treatment with antidepressants
  • Bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Food PreferencesFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Kristine Færch, PhD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be aware of the study visit assignment during the study visit when exposed to the experimental stimuli, but not beforehand. Investigators will be aware also before the study visit.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: All participants will complete all three study visits. The visits differ in the employed experimental stimuli, namely the pictures (sweet food, savoury food, non-food).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 8, 2023

Study Start

January 17, 2023

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations