Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05719142
Other study ID # RM-110729522
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2023
Est. completion date June 29, 2023

Study information

Verified date August 2023
Source Steno Diabetes Center Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Watching television is associated with an increased risk of being overweight. On the more modern internet-based digital media food represents a major content category. The vast majority of people in the United States look at screens during the majority of their meals. It, therefore, seems prudent to study the eating behavioral impact of common (food-related) digital media habits. One particularly popular digital media type is food pictures. While food pictures can elicit hunger, they might also cause satiation. One study showed that rating the taste of 60 (vs. 20) food pictures of a salty (vs. sweet) taste decreased liking for subsequently consumed peanuts (i.e., a salty food). The mechanism behind this finding is an implicit mental simulation of food consumption - necessary to make a hedonic judgment - and a process that spontaneously occurs at the sight of food. Analogous research in mental imagery - explicit mental simulation - similarly found that repeated imagined consumption of a food can decrease subsequent actual intake of that same food. Cephalic phase responses are conditioned or learned physiological anticipatory responses to food. In the subsequent century, scientific investigation has moved beyond saliva to also include hormones measured in blood. Many cephalic phase responses depend on vagus nerve efferent activation. Pancreatic polypeptide is the most robust and reliable proxy for such vagal activity. Researchers have used a multitude of methods to trigger the cephalic phase responses, including actual food consumption, sham feeding (i.e., orosensory stimulation without absorption), and visual, olfactory, and cognitive cues. There are some indications that cephalic phase vagal activation might be sensory-specific, i.e., that the vagus nerve is differentially stimulated by sweet and salty stimuli. Pancreatic polypeptide responds differently to (modified) sham feeding solid food with palatable or unpalatable levels of sweet or salty taste while keeping the macronutrient content constant. Specifically, the palatable-sweet conditions had a significantly increased pancreatic polypeptide response compared to the salty conditions. Contrary to the common belief that sweetness is universally liked, researchers have consistently found marked differences in individuals' taste preferences. Recent research identified FGF21 as a key physiological determinant of sweet taste liking. Fasting FGF21 blood concentrations are lower in participants classified as sweet taste likers compared to dislikers, based on a taste preference questionnaire. FGF21 gene variants were also predictive of habitual candy intake. The agreement between FGF21 blood levels and phenotypical assessment methods of sweet taste liking is unknown. Overall, it seems plausible to speculate that cephalic phase responses manifest sensory-specific differences based on both stimulus and participant. In the last decade, researchers have begun to study cephalic phase responses to food pictures. None of the studies measured vagal activation via pancreatic polypeptide secretion. While the studies that included a post-stimulus meal challenge replicated established beneficial effects on postprandial glucose metabolism, none of them found explicit evidence for a picture-induced cephalic phase insulin response. However, it must be noted that blood sampling schedules were suboptimal and the studies, therefore, unlikely to capture any effect. The study of cephalic phase ghrelin secretion also yielded inconclusive results. Some research showed a significant increase in total ghrelin levels after exposure to food pictures, but not after non-food pictures. However, other research did not confirm this finding. Ghrelin is of principal importance in hunger regulation, and known to cause food intake in humans. In rats, visual cues increase brain activity and food anticipatory behavior similar to exogenously administered ghrelin. And yet, in another study, participants exposed to food pictures before an ad libitum buffet consumed as many calories as those exposed to non-food pictures. One important limitation of the aforementioned investigations is that all exposed their participants to 45-50 pictures, depicting a large variety of food and tastes. Some researchers used picture sets of food with different macronutrient profiles, but the food tastes still widely varied within each set. In contrast, prior research using actual food as visual (and olfactory) stimuli exposed participants only to a very limited food selection. Using highly varied food stimuli stands in contrast to the stimulus repetition paradigm, as well as a particular study, which exposed participants to food pictures of a specific taste (i.e., sweet or salty). Furthermore, research has long established that food variety increases energy intake, essentially delaying stimulus habituation. This effect appears to be highly psychological. For example, satiation to one kind of jelly bean can be reset simply by recalling the other kinds they had consumed some minutes ago. An experiment controlling for stimulus taste would elucidate the sensory-specific physiological and behavioral responses to food cues. Finally, cephalic phase responses may relate to individual tendencies in eating behavior. One study investigating the relationship between the cephalic phase insulin response and dietary restraint, disinhibition, or hunger, as measured by the Three-Factor Eating Questionnaire, did not find any association. However, no study to date has investigated the relationship between external eating tendencies and cephalic phase responses. External eating refers to food consumption in response to environmental cues. One might speculate that, beyond purely neurological influences, endocrine cephalic phase responses mediate such behavior. The study foresees three participant visits. The three visits mainly differ in the administered visual stimuli. The procedure is described below. Participants will arrive in the morning around 08:00 after an overnight fast. At 08:15 an investigator will draw an initial baseline blood sample. In the following 15 minutes, an investigator will introduce the image viewing task. Participants will be seated in front of a computer monitor, equipped with a screen-based eye-tracker. An investigator will subsequently configure the eye-tracker and allow participants to acclimatize to the setup. At 08:30, an investigator will draw a second baseline blood sample, and subsequently start the 15 minutes image viewing task. At 08:45, participants will be presented with breakfast choices, shown on the computer monitor. Thus, they will freely choose breakfast type and amount at each visit, which an investigator will prepare and serve at 09:00. Biometric data will be collected during the full image viewing and food choice tasks. While waiting for the breakfast to be prepared, participants will watch a neutral video. After breakfast consumption, participants will rate their post-ingestive sensations. During the first visit, participants will also undergo basic anthropometric measurements. During the last visit, participants will also complete the Sweet Liker test, as well as fill out selected eating behavior questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 29, 2023
Est. primary completion date June 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Normal or corrected-to-normal vision and no color-blindness - Danish understanding Exclusion Criteria: - 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 - Self-reported weight change (>5 kg) within three months before inclusion - 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 - Alcohol/drug abuse or in treatment with disulfiram (Antabus) at the time of inclusion

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Steno Diabetes Center Copenhagen Herlev

Sponsors (2)

Lead Sponsor Collaborator
Steno Diabetes Center Copenhagen University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hunger (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). 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)
Secondary Desire to eat something (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). 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)
Secondary Desire for something sweet (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). 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)
Secondary Desire for something salty (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). 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)
Secondary Desire for something fatty (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). 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)
Secondary Breakfast liking (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). Measured after meal consumption (t = 45 minutes) and compared between each visit (at least one week between each visit).
Secondary Feelings of satisfaction (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). Measured after meal consumption (t = 45 minutes) and compared between each visit (at least one week between each visit).
Secondary Feelings of fullness (self-reported, VAS) Assessed by a Visual Analogue Scale, anchored "Not at all" (0) and "Extremely" (100). Measured after meal consumption (t = 45 minutes) and compared between each visit (at least one week between each visit).
Secondary Eye movement Eye movement patterns are recorded by an eye-tracker, the data processed and respective metrics (including gaze duration bias, gaze direction bias, fixations, saccades, pupil size/dilation, distance to screen, ocular vergence and blinks to measure attention) calculated by the iMotions software. Measured during t = 0-15 minutes, and compared between each visit (at least one week between each visit).
Secondary Food choice Participants will be able to select from a menu of four meals, consisting of two sweet and savoury options. The basic taste (sweet/savoury) of the chosen food will be compared between the visits. Captured during t = 15 minutes, and compared between each visit (at least one week between each visit).
Secondary Food intake (kcal) Participants will be able to select from a menu of four portion sizes. After consumption of the meal, the remaining food will be weighed. The outcome measure is based on the actually consumed energy content. Portion size is captured at t = 15 minutes. Actual food intake (kcal) is measured after meal completion (t = 45 minutes), and compared between each visit (at least one week between each visit).
Secondary Glucose concentrations (mmol/l) 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 Insulin concentrations (µg/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 Ghrelin 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 FGF21 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 GLP-1 concentrations (pmol/l) 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 Peptide YY concentrations (pmol/l) 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)
See also
  Status Clinical Trial Phase
Completed NCT03117374 - Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy N/A
Completed NCT04025099 - Internal Cues Versus External Cues for Eating and Activity N/A
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT05485168 - Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT03850990 - Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss N/A
Completed NCT02470949 - Influence of a Monopoly Game on Subtle Behaviors N/A
Recruiting NCT01863212 - The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects N/A
Completed NCT02729675 - Innovative Approaches to Increase F&V Intake Thru Worksites Phase 2
Completed NCT05405244 - Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM Phase 3
Completed NCT04971811 - Effects of Energy Density on Self-served Snacks in Preschool Children N/A
Completed NCT05019872 - Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture N/A
Completed NCT04605224 - Effectiveness of a Culinary Class on Food Literacy and Eating Behaviours of Francophone High School Students
Not yet recruiting NCT06448117 - Mind Nutrition Study: Nutrition in the Prevention of Depressiveness and Sustaining Work Ability N/A
Recruiting NCT04526743 - Eating Behavior and Weight Trajectory After Bariatric Surgery
Active, not recruiting NCT05026411 - Food Reward Circuit Change by Orthodontics N/A
Completed NCT05173311 - Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance N/A
Completed NCT05149066 - #KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents N/A
Completed NCT03779321 - Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A