Clinical trial: Effect of Tableware Visual Cues on Portion Control and Eating Rate (NCT03610776)

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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction