Clinical trial NCT03610776: Effect of Tableware Visual Cues on Portion Control and Eating Rate
Official title: Role of Visual Cues in the Regulation of Portion Size and the Cephalic Satiety Response in Lean and Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portion Size
Keywords: Portion control plate
Visual attention
Eating rate
Cephalic satiety response
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Gobierno de Navarra
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Precise Portions Nutrition Learning Systems
name: University of Bristol
First posted: 2018-08-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, cross-over (within-subjects) design.
Primary purpose: BASIC_SCIENCE

Brief summary: Randomised within subjects cross-over study (n=94) exploring the cognitive and physiological processes associated with portion control. Participants will eat a self-served lunch using a portion control plate vs. a conventional (control) plate on two separate occasions under a controlled laboratory environment. Portion size, meal micro-structure, attention, memory and satiety markers will be analysed. The portion control plate is a prototype designed in collaboration with the commercial partner for this study and is based on published evidence. It includes sectors and pictures indicating amounts to serve from starchy food, protein and vegetables. The control plate will be of the same background colour, size and shape but without any pictures or demarcations. The main study outcome is attention time on areas of interest in the plate corresponding to main foods groups, across plate conditions.

Detailed description: The size and design of tableware have been proposed as a potentially effective strategy to modulate how much is eaten at a meal. The mechanisms by which specific tableware may work however are not known, in particular the cognitive processes associated with visual stimuli. In this covert trial, 68 women (34 overweight or obese) and 26 lean men (exploratory sub-study) will self-serve and consume food from a laboratory buffet using a portion control plate with visual stimuli for appropriate amounts of main food groups, or a conventional plate, on two different days in random order. On both sessions participants will complete behavioural and cognitive tests to measure visual attention during the meal (eyetracking device), meal microstructure (Universal Eating Monitor), episodic memory for portion sizes (computerised test), portion size choice, food intake, subjective appetite and satiety, cephalic and intestinal satiety responses. Further behavioural tests include meal liking, expected satiety, portion size perceptions and tool acceptance ratings. The main study outcome is difference in proportional dwell time on areas of interest in the plate corresponding to main foods groups (women), or difference in bite size (men) across conditions. Secondary outcomes for all subjects include: portion size for overall meal and meal components, eating rate, bite size, deceleration rate, portion size memory error, portion size norms, portion control self-efficacy, tool acceptance, energy compensation for the rest of the day, plus blood insulin, glucose, pancreatic polypeptide and ghrelin up to 90 min post-meal (sub-sample of 34 women, 50% being overweight/obese). Analyses by gender and BMI sub-groups will be applied when possible. The results of this study will help to better understand the potential mechanisms by which portion control tools with visual cues may work, and to improve the design of current instruments for their application in nutritional interventions.

Eligibility criteria: Inclusion Criteria:

1. Women and men aged 18-60 years.
2. For women, having a BMI between 18.5 and 35 kg/m2 (both included); for men having a BMI between 18.5 and 25 kg/m2 (both included).
3. Healthy as determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant for the study by the study medical doctor.
4. Not taking any medication that may affect sight, gastro-intestinal function or appetite. Volunteers taking medication for clinical conditions that may affect the above functions will be eligible if they report no side effects and the dose has been stable for at least 3 months prior to commencement of the study.
5. Consuming breakfast and lunch regularly (at least 5 days per week).
6. Liking of the study foods defined by a score of \>40 mm of the Liking VAS questionnaire, for each compulsory meal component.
7. Able to consume food without the need for prescription glasses (contact lenses are allowed).
8. Able to understand and be willing to sign the informed consent form and to follow all the study procedures and requirements.

Exclusion Criteria:

1. Deficient nutrition or hydration status at the time of recruitment.
2. Abnormal gastro-intestinal function or structure such as malformation, angiodysplasia, active peptic ulcer, and chronic inflammatory or malabsorptive diseases, even if at the time of recruitment the volunteer is not taking medication for such conditions (e.g. anti-inflammatory drugs).
3. History of gastro-intestinal surgery with permanent sequels (i.e. gastroduodenostomy).
4. History of liver disease.
5. History of cancer or receiving treatment for cancer.
6. Diabetes mellitus.
7. Food allergy, food restriction or avoidance of any of the study foods (e.g. vegetarian).
8. History of mental illness, or being under active treatment for mental illness (e.g. psychiatric disorder), whenever their condition affects their ability to comprehend or follow the requirements of the study in full, or when their condition affects short-term memory (e.g. Alzheimer disease).
9. Presence of an eating disorder defined as a score \>19 on the Eating Attitudes Test (EAT-26).
10. Diagnosed or suspected epilepsy or photosensitive epilepsy (e.g. experiencing an "aura" or odd sensations while watching images or patterns on a computer screen).
11. Wearing a pacemaker or other medical electronic device.
12. Currently dieting to lose weight.
13. Smoking \> 7 cigarettes per week.
14. Consuming \>14 units of alcohol intake per week in women, or \>21 units per week in men.
15. Performing \>9 h of intense physical activity per week.
16. Pregnancy or lactation.
17. Having received formal portion size education as part of a university degree (e.g. Dietetics, Human Nutrition, Psychology if relevant).
18. Being familiar with the nature of the covert measures involved in the study (i.e. measure of eating speed and bite size).
19. Volunteers for which insufficient collaboration may be foreseen, or whom the investigator has grounds to believe that they may experience difficulty in following the study procedures.

Primary outcomes:
measure: Dwell time difference (women)
timeFrame: Month 24
measure: Bite size difference (men)
timeFrame: Month 24
Secondary outcomes:
measure: Eating rate difference
timeFrame: Month 24
measure: Bite size difference (women)
timeFrame: Month 24
measure: Deceleration rate difference
timeFrame: Month 24
measure: Meal duration difference
timeFrame: Month 24
measure: Dwell time difference (men)
timeFrame: Month 24
measure: Difference in portion size at meal
timeFrame: Month 24
measure: Percent memory reconstruction error (Portion Control Plate)
timeFrame: Month 21
measure: Percent memory reconstruction error (conventional plate)
timeFrame: Month 21
measure: Percent memory reconstruction error difference
timeFrame: Month 24
measure: Percent energy compensation (EC)
timeFrame: Month 21
measure: Percent energy compensation difference
timeFrame: Month 24
measure: Portion size norms
timeFrame: Month 21
measure: Portion size norms difference
timeFrame: Month 24
measure: Liking for the meal differences
timeFrame: Month 24
measure: Baseline subjective appetite
timeFrame: Month 21
measure: Baseline subjective satiety
timeFrame: Month 21
measure: Baseline subjective thirst
timeFrame: Month 21
measure: Baseline subjective nausea
timeFrame: Month 21
measure: Post-meal subjective appetite
timeFrame: Month 21
measure: Post-meal subjective satiety
timeFrame: Month 21
measure: Post-meal subjective thirst
timeFrame: Month 21
measure: Post-meal subjective nausea
timeFrame: Month 21
measure: 3 h subjective appetite
timeFrame: Month 21
measure: 3 h subjective satiety
timeFrame: Month 21
measure: 3 h subjective thirst
timeFrame: Month 21
measure: 3 h subjective nausea
timeFrame: Month 21
measure: Difference in subjective appetite and satiety scores
timeFrame: Month 24
measure: Difference in expected satiation for the meal
timeFrame: Month 24
measure: Baseline blood glucose
timeFrame: Month 21
measure: Post-meal blood glucose
timeFrame: Month 21
measure: Difference in post-meal blood glucose
timeFrame: Month 21
measure: Baseline blood insulin
timeFrame: Month 21
measure: Post-meal blood insulin
timeFrame: Month 21
measure: Difference in post-meal blood insulin
timeFrame: Month 24
measure: Baseline blood pancreatic polypeptide
timeFrame: Month 21
measure: Post-meal blood pancreatic polypeptide
timeFrame: Month 21
measure: Difference in post-meal blood pancreatic polypeptide
timeFrame: Month 24
measure: Baseline blood ghrelin
timeFrame: Month 21
measure: Post-meal blood ghrelin
timeFrame: Month 21
measure: Difference in post-meal blood ghrelin
timeFrame: Month 24
measure: Body Mass Index
timeFrame: Month 18
measure: Age
timeFrame: Month 18
measure: Eating behaviour profile from the Three Factor Eating Questionnaire (TFEQ)
timeFrame: Month 21
measure: Eating behaviour profile from the Eating Attitudes Test (EAT-26)
timeFrame: Month 18
measure: Difference in portion control self-efficacy
timeFrame: Month 24
measure: Difference in portion tool acceptance
timeFrame: Month 24
measure: Self-reported ethnicity
timeFrame: Month 18
measure: Household composition
timeFrame: Month 18
measure: Take away food consumption
timeFrame: Month 18
measure: Home-made meal consumption
timeFrame: Month 18
measure: Cooking pattern
timeFrame: Month 18
measure: Previous experience with portion tools
timeFrame: Month 18
measure: Food intake for remaining of the day
timeFrame: Month 21
Other outcomes:
measure: Meal component palatability scores
timeFrame: Month 18
measure: Smoking frequency
timeFrame: Month 18
measure: Physical activity frequency
timeFrame: Month 18
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research, University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Eva Almiron-Roig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almiron-Roig E, Dominguez A, Vaughan D, Solis-Trapala I, Jebb SA. Acceptability and potential effectiveness of commercial portion control tools amongst people with obesity. Br J Nutr. 2016 Dec;116(11):1974-1983. doi: 10.1017/S0007114516004104. Epub 2016 Dec 15.
citation: Almiron-Roig E, Palla L, Guest K, Ricchiuti C, Vint N, Jebb SA, Drewnowski A. Factors that determine energy compensation: a systematic review of preload studies. Nutr Rev. 2013 Jul;71(7):458-73. doi: 10.1111/nure.12048. Epub 2013 Jun 10.
citation: Fast LC, Harman JJ, Maertens JA, Burnette JL, Dreith F. Creating a measure of portion control self-efficacy. Eat Behav. 2015 Jan;16:23-30. doi: 10.1016/j.eatbeh.2014.10.009. Epub 2014 Nov 1.
citation: Vargas-Alvarez MA, Al-Sehaim H, Brunstrom JM, Castelnuovo G, Navas-Carretero S, Martinez JA, Almiron-Roig E. Development and validation of a new methodological platform to measure behavioral, cognitive, and physiological responses to food interventions in real time. Behav Res Methods. 2022 Dec;54(6):2777-2801. doi: 10.3758/s13428-021-01745-9. Epub 2022 Jan 31.