Portion SizePORTIONSNCT03610776
Effect of Tableware Visual Cues on Portion Control and Eating Rate
A study testing Conventional plate in people with Portion Size, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Portion Size
- What is being tested?
- Conventional plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2017to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Pregnancy or lactation.
- Having received formal portion size education as part of a university degree (e.g. Dietetics, Human Nutrition, Psychology if relevant).
- Being familiar with the nature of the covert measures involved in the study (i.e. measure of eating speed and bite size).
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: Role of Visual Cues in the Regulation of Portion Size and the Cephalic Satiety Response in Lean and Overweight Subjects
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.
Read the 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.
- Conditions
- Portion Size
- Being tested
- Portion control plate, Conventional plate
- Keywords
- Portion control plate, Visual attention, Eating rate, Cephalic satiety response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portion control plateDevice
Also called Calibrated plate
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.
Conventional plateDevice
Also called Control plate
Conventional plate without demarcations or images, 25 cm in diameter, enamel, white.
| Study group | Role | What they receive |
|---|---|---|
| Portion control plate | Experimental | Portion control plate first (50% of subjects experiment with this plate first) Receives: Device: Portion control plate |
| Conventional plate | Active comparator | Conventional plate first (50% of subjects experiment with this plate first) Receives: Device: Conventional plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 24
Secondary outcomes (53)
Eating rate difference
Difference in grams of food consumed per minute as measured by the Universal Eating Monitor, between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Bite size difference (women)
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 conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Deceleration rate difference
Difference in the change in eating rate over the course of the meal measured in grams per squared second, as recorded by the Universal Eating Monitor, between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Meal duration difference
Difference in the duration of the meal in minutes, starting when the investigator places the food on the table and finishing when the volunteer pressed the bell, between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Dwell time difference (men)
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 conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Difference in portion size at meal
Difference in portion sizes in grams for the complete meal and for each meal component (i.e. rice, vegetables, meatballs, bread, fruit, condiments and water), between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Percent memory reconstruction error (Portion Control Plate)
Percent error between recalled and real portion size calculated by subtracting the recalled portion size for each meal component at 3 hours post-meal, from the actual portion sizes chosen during the test meal and dividing by the actual portion size, using data from a computer-based memory reconstruction task (XnConvert software), for the Portion Control Plate condition. Interpreted as 0% = perfect match between recalled and actual portion size.
Measured: Month 21
Percent memory reconstruction error (conventional plate)
Percent error between recalled and real portion size calculated by subtracting the recalled portion size for each meal component at 3 hours post-meal, from the actual portion sizes chosen during the test meal and dividing by the actual portion size, using data from a computer-based memory reconstruction task (XnConvert software), for the conventional plate condition. Interpreted as 0% = perfect match between recalled and actual portion size.
Measured: Month 21
Percent memory reconstruction error difference
Difference in the percent memory reconstruction error for each meal component at 3 hours post-meal, between the Portion Control Plate and the conventional plate condition.
Measured: Month 24
Percent energy compensation (EC)
Energy adjustment after the meal and for the remaining of the day, calculated from food intake data collected via an 8h food diary and using a published algorithm (Almiron-Roig et al. 2013). Interpreted as EC of 100% = perfect compensation; <100% = undercompensation; >100% overcompensation.
Measured: Month 21
Percent energy compensation difference
Difference in percent energy compensation after the meal and for the remaining of the day, between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Portion size norms
Visual analogue scale ratings (0 -100 mm) for habitual portion size for the meal, rice, vegetables and meatballs consumed during the test meal. Interpreted as: a score of 50 mm = the chosen portion equals the habitual portion size; >50 mm = chosen portion is smaller than habitual; <50 mm = chosen portion is larger than habitual.
Measured: Month 21
Portion size norms difference
Difference in Visual Analogue Scale ratings for portion size norms for the whole meal, rice, vegetables and meatballs between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Liking for the meal differences
Difference in visual analogue scale ratings (0-100 mm) for Liking of the meal after consumption between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Baseline subjective appetite
Visual analogue scale ratings (0-100 mm) for perceived hunger before the meal (time 0)
Measured: Month 21
Baseline subjective satiety
Visual analogue scale ratings (0-100 mm) for perceived fullness before the meal (time 0)
Measured: Month 21
Baseline subjective thirst
Visual analogue scale ratings (0-100 mm) for perceived thirst before the meal (time 0)
Measured: Month 21
Baseline subjective nausea
Visual analogue scale ratings (0-100 mm) for perceived nausea before the meal (time 0)
Measured: Month 21
Post-meal subjective appetite
Visual analogue scale ratings (0-100 mm) for perceived hunger immediately after the meal (time 1)
Measured: Month 21
Post-meal subjective satiety
Visual analogue scale ratings (0-100 mm) for perceived fullness immediately after the meal (time 1)
Measured: Month 21
Post-meal subjective thirst
Visual analogue scale ratings (0-100 mm) for perceived thirst immediately after the meal (time 1)
Measured: Month 21
Post-meal subjective nausea
Visual analogue scale ratings (0-100 mm) for perceived nausea immediately after the meal (time 1)
Measured: Month 21
3 h subjective appetite
Visual analogue scale ratings (0-100 mm) for perceived hunger 3 hours after consuming the meal (time 2)
Measured: Month 21
3 h subjective satiety
Visual analogue scale ratings (0-100 mm) for perceived fullness 3 hours after consuming the meal (time 2)
Measured: Month 21
3 h subjective thirst
Visual analogue scale ratings (0-100 mm) for perceived thirst 3 hours after consuming the meal (time 2)
Measured: Month 21
3 h subjective nausea
Visual analogue scale ratings (0-100 mm) for perceived nausea 3 hours after consuming the meal (time 2)
Measured: Month 21
Difference in subjective appetite and satiety scores
Difference in scores of visual analogue scale ratings (0-100 mm) for perceived hunger, fullness, thirst and nausea at baseline, post-meal and 3 hours after consuming the meal, between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Difference in expected satiation for the meal
Difference in visual analogue scale rating (0-100 mm) before consuming the meal, between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Baseline blood glucose
Blood glucose levels before starting the meal
Measured: Month 21
Post-meal blood glucose
Blood glucose levels at 5, 10, 30, 60 and 90 min after starting the meal
Measured: Month 21
Difference in post-meal blood glucose
Difference in blood glucose levels at 5, 10, 30, 60 and 90 min after starting the meal between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 21
Baseline blood insulin
Blood insulin levels before starting the meal
Measured: Month 21
Post-meal blood insulin
Blood insulin levels at 5, 10, 30, 60 and 90 min after starting the meal
Measured: Month 21
Difference in post-meal blood insulin
Difference in blood insulin levels at 5, 10, 30, 60 and 90 min after starting the meal between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Baseline blood pancreatic polypeptide
Blood pancreatic polypeptide levels before starting the meal
Measured: Month 21
Post-meal blood pancreatic polypeptide
Blood pancreatic polypeptide levels at 5, 10, 30, 60 and 90 min after starting the meal
Measured: Month 21
Difference in post-meal blood pancreatic polypeptide
Difference in blood pancreatic polypeptide levels at 5, 10, 30, 60 and 90 min after starting the meal between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Baseline blood ghrelin
Blood ghrelin levels before starting the meal
Measured: Month 21
Post-meal blood ghrelin
Blood ghrelin levels at 5, 10, 30, 60 and 90 min after starting the meal
Measured: Month 21
Difference in post-meal blood ghrelin
Difference in blood ghrelin levels at 5, 10, 30, 60 and 90 min after starting the meal between conditions (Portion Control Plate vs. conventional plate).
Measured: Month 24
Body Mass Index
Weight in kilograms divided by height in squared meters measured at the start of the trial.
Measured: Month 18
Age
Age in years measured at the start of the trial.
Measured: Month 18
Eating behaviour profile from the Three Factor Eating Questionnaire (TFEQ)
Restraint, disinhibition and susceptibility to hunger scores from the Three Factor Eating Questionnaire for the Spanish population (Sánchez-Carracedo et al. 1999, Psicol Conduct 7:393-416) measured at the end of the trial.
Measured: Month 21
Eating behaviour profile from the Eating Attitudes Test (EAT-26)
Susceptibility to eating disorders score using the Eating Attitudes Test (EAT-26) the Spanish population (Rivas et al. 2010; Span J Psychol 13:1044-1056) measured at the start of the trial.
Measured: Month 18
Difference in portion control self-efficacy
Difference in portion control self-efficacy score derived from the Portion Control Self-Efficacy Scale (Fast et al.2015) between conditions (Portion Control Plate vs. conventional plate). The scale ranges from 1 to 5. A combined score will be obtained for questions 1,2, 3, 5, 7,8 and the reverse of questions 4 and 6, by adding up all the scores from each of the 8 Likert scales, and dividing the sum by 8. A score between 1-2.5 will be interpreted as 'none to low self-efficacy'; a score between 2.5-3.5 will be interpreted as 'neutral self-efficacy', a score between 3.5-5 will be interpreted as 'medium to high self-efficacy'.
Measured: Month 24
Difference in portion tool acceptance
Difference in portion tool acceptance score derived from a published questionnaire (Almiron-Roig et al., 2016) between conditions (Portion Control Plate vs. conventional plate). A combined score will be obtained for questions a, b, c, e, f, g and the reverse of d by adding up all the scores from each of the 4 Likert scales, and dividing the sum by 7. A score between 1-2.5 will be interpreted as 'none to low acceptance'; a score between 2.5-3.5 will be interpreted as 'neutral acceptance', a score between 3.5-5 will be interpreted as 'medium to high acceptance'.
Measured: Month 24
Self-reported ethnicity
Ethnicity group defined using a check-list, measured at the start of the trial.
Measured: Month 18
Household composition
Number of adults and children aged 18 or less living in the same household (checklist) measured at the start of the trial.
Measured: Month 18
Take away food consumption
Frequency of take away food consumption (checklist), measured at the start of the trial.
Measured: Month 18
Home-made meal consumption
Frequency of home-made meal consumption (checklist), measured at the start of the trial.
Measured: Month 18
Cooking pattern
Cooking for self only vs. cooking for self and others (checklist), measured at the start of the trial.
Measured: Month 18
Previous experience with portion tools
Previous experience with portioning utensils, portion control tools, measuring utensils etc. (open ended question), measured at the start of the trial.
Measured: Month 18
Food intake for remaining of the day
8h food record to complete after the laboratory test meal, for both conditions (Portion Control Plate and conventional plate).
Measured: Month 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start19 Jun 2017
- Primary completion31 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Portion SizeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, cross-over (within-subjects) design.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Navarra, Consorcio Centro de Investigación Biomédica en Red (CIBER), Precise Portions Nutrition Learning Systems, University of Bristol
- Responsible party
- Sponsor
- Investigators
- Eva Almiron-Roig, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610776
- Sponsor's protocol ID
- CIN-01-17
- Acronym
- PORTIONS
- Status last verified
- Oct 2019
- First submitted
- 16 Jul 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 27976604Almiron-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.
PubMed 23815144Fast 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.
PubMed 25464062Vargas-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.
PubMed 35102518
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Visual Cues in the Regulation of Portion Size and the Cephalic Satiety Response in Lean and Overweight Subjects
- ClinicalTrials.gov ID
- NCT03610776
- Acronym / sponsor ID
- PORTIONS / CIN-01-17
- Conditions
- Portion Size
- Keywords
- Portion control plate, Visual attention, Eating rate, Cephalic satiety response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Government of Navarra, Consorcio Centro de Investigación Biomédica en Red (CIBER), Precise Portions Nutrition Learning Systems, University of Bristol
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, cross-over (within-subjects) design.
| Arm | Type | Receives |
|---|---|---|
| Portion control plate | Experimental | Device: Portion control platePortion control plate first (50% of subjects experiment with this plate first) |
| Conventional plate | Active comparator | Device: Conventional plateConventional plate first (50% of subjects experiment with this plate first) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portion control plateAlso: Calibrated platePortion control plate including demarcations and pictures for recommended amounts of main food groups (starch, protein and vegetables), 25 cm in diameter, enamel, white background. | Device | Portion control plate |
| Conventional plateAlso: Control plateConventional plate without demarcations or images, 25 cm in diameter, enamel, white. | Device | Conventional plate |
Primary outcome
Dwell time difference (women)
Time frame: Month 24
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.
Bite size difference (men)
Time frame: Month 24
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.
53 secondary outcomes
Eating rate difference
Time frame: Month 24
Bite size difference (women)
Time frame: Month 24
Deceleration rate difference
Time frame: Month 24
Meal duration difference
Time frame: Month 24
Dwell time difference (men)
Time frame: Month 24
Difference in portion size at meal
Time frame: Month 24
Percent memory reconstruction error (Portion Control Plate)
Time frame: Month 21
Percent memory reconstruction error (conventional plate)
Time frame: Month 21
Percent memory reconstruction error difference
Time frame: Month 24
Percent energy compensation (EC)
Time frame: Month 21
Percent energy compensation difference
Time frame: Month 24
Portion size norms
Time frame: Month 21
Portion size norms difference
Time frame: Month 24
Liking for the meal differences
Time frame: Month 24
Baseline subjective appetite
Time frame: Month 21
Baseline subjective satiety
Time frame: Month 21
Baseline subjective thirst
Time frame: Month 21
Baseline subjective nausea
Time frame: Month 21
Post-meal subjective appetite
Time frame: Month 21
Post-meal subjective satiety
Time frame: Month 21
Post-meal subjective thirst
Time frame: Month 21
Post-meal subjective nausea
Time frame: Month 21
3 h subjective appetite
Time frame: Month 21
3 h subjective satiety
Time frame: Month 21
3 h subjective thirst
Time frame: Month 21
3 h subjective nausea
Time frame: Month 21
Difference in subjective appetite and satiety scores
Time frame: Month 24
Difference in expected satiation for the meal
Time frame: Month 24
Baseline blood glucose
Time frame: Month 21
Post-meal blood glucose
Time frame: Month 21
Difference in post-meal blood glucose
Time frame: Month 21
Baseline blood insulin
Time frame: Month 21
Post-meal blood insulin
Time frame: Month 21
Difference in post-meal blood insulin
Time frame: Month 24
Baseline blood pancreatic polypeptide
Time frame: Month 21
Post-meal blood pancreatic polypeptide
Time frame: Month 21
Difference in post-meal blood pancreatic polypeptide
Time frame: Month 24
Baseline blood ghrelin
Time frame: Month 21
Post-meal blood ghrelin
Time frame: Month 21
Difference in post-meal blood ghrelin
Time frame: Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Background: PubMed 27976604Almiron-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.
- Background: PubMed 23815144Almiron-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.
- Background: PubMed 25464062Fast 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.
- Derived from this study: PubMed 35102518Vargas-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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Almiron-Roig, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional plate in people with Portion Size, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dwell time difference (women) (time frame: Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610776, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.