Effect of Tableware Visual Cues on Portion Control and Eating Rate

NCT03610776 | Completed

• 1 other identifier: CIN-01-17
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Portion Size

Keywords

Portion control plate; Visual attention; Eating rate; Cephalic satiety response

Outcome Measures

Primary Outcomes (2)

• Dwell time difference (women)

  Difference in proportional dwell time on three areas of interest in the plate corresponding to main food groups i.e. starch, protein and vegetables, measured in milliseconds, as a proxy for attention levels, between the Portion Control Plate condition and the conventional plate condition.

  Month 24

• Bite size difference (men)

  Difference in the amount of food loaded on the fork estimated from the difference in grams between two consecutive weight records as measured by the Universal Eating Monitor, between the Portion Control Plate condition and the conventional plate condition.

  Month 24

Secondary Outcomes (53)

• Eating rate difference

  Month 24

• Bite size difference (women)

  Month 24

• Deceleration rate difference

  Month 24

• Meal duration difference

  Month 24

• Dwell time difference (men)

  Month 24

Other Outcomes (3)

• Meal component palatability scores

  Month 18

• Smoking frequency

  Month 18

• Physical activity frequency

  Month 18

Study Arms (2)

Portion control plate

EXPERIMENTAL

Portion control plate first (50% of subjects experiment with this plate first)

Device: Portion control plate

Conventional plate

ACTIVE COMPARATOR

Conventional plate first (50% of subjects experiment with this plate first)

Device: Conventional plate

Interventions

Portion control plate DEVICE

Portion control plate including demarcations and pictures for recommended amounts of main food groups (starch, protein and vegetables), 25 cm in diameter, enamel, white background.

Also known as: Calibrated plate

Portion control plate

Conventional plate DEVICE

Conventional plate without demarcations or images, 25 cm in diameter, enamel, white.

Also known as: Control plate

Conventional plate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men aged 18-60 years.
• 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).
• 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.
• 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.
• Consuming breakfast and lunch regularly (at least 5 days per week).
• Liking of the study foods defined by a score of \>40 mm of the Liking VAS questionnaire, for each compulsory meal component.
• Able to consume food without the need for prescription glasses (contact lenses are allowed).
• Able to understand and be willing to sign the informed consent form and to follow all the study procedures and requirements.

You may not qualify if:

• Deficient nutrition or hydration status at the time of recruitment.
• 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).
• History of gastro-intestinal surgery with permanent sequels (i.e. gastroduodenostomy).
• History of liver disease.
• History of cancer or receiving treatment for cancer.
• Diabetes mellitus.
• Food allergy, food restriction or avoidance of any of the study foods (e.g. vegetarian).
• 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).
• Presence of an eating disorder defined as a score \>19 on the Eating Attitudes Test (EAT-26).
• Diagnosed or suspected epilepsy or photosensitive epilepsy (e.g. experiencing an "aura" or odd sensations while watching images or patterns on a computer screen).
• Wearing a pacemaker or other medical electronic device.
• Currently dieting to lose weight.
• Smoking \> 7 cigarettes per week.
• Consuming \>14 units of alcohol intake per week in women, or \>21 units per week in men.
• Performing \>9 h of intense physical activity per week.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Gobierno de Navarra: collaborator
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Precise Portions Nutrition Learning Systems: collaborator
• University of Bristol: collaborator

Study Sites (1)

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (4)

• 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.

  PMID: 27976604 BACKGROUND

• 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.

  PMID: 23815144 BACKGROUND

• 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.

  PMID: 25464062 BACKGROUND

• 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.

  PMID: 35102518 DERIVED

Study Officials

• Eva Almiron-Roig, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible due to the nature of the intervention (portion control vs. conventional plate).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, cross-over (within-subjects) design.

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: June 19, 2017
• Primary Completion: May 31, 2020
• Study Completion: June 15, 2020
• Last Updated: June 18, 2020

Record last verified: 2019-10

Locations

ES (1)