Opportunities for Food Reformulation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the independent and additive effects of food texture and energy density on food and energy intake compared to a control condition.

Detailed Description
-----------------
Study design: The study has a 2x2 randomized crossover design. All participants receive 5 treatments and are their own control. Study population: Healthy adults (n=75) between 18-55 years old with a BMI between 18.5-30 kg/m2. Intervention: Participants will join 5 test days during which they receive, 5 test meals (lunch). The 5 test meals of this study are: 1.) low energy density, hard texture (slow eating rate) 2.) low energy density, soft texture (fast eating rate) 3.) High energy density, hard texture (slow eating rate) 4.) High energy density, soft texture (fast eating rate) 5.) Average energy density and medium hard texture (control). During eating and before and after eating the weight of the plate will be measured to determine intake. Additionally, participants will be recorded on video to determine eating behaviour (number of bites, chews and oral processing duration). The order in which participants will receive the diets will be randomized. The evening before and during each test day participants will keep a food and exercise diary. Main study parameters/endpoints: The main study outcomes are food and energy intake of each lunch meal. Secondary outcomes are, eating behaviour characteristics measured by video (eating rate (g/min and bites/min), number of chews (chews/bite and chews/gram), bite size (gram/bite), oral processing duration (seconds), appetite (hunger, fullness, desire to eat, desire to eat sweet, desire to eat savoury, prospective consumption) and sensory characteristics (liking (taste + smell), desire to eat the meal, expected satiation, sweet, savoury, smoothness, chewiness, thickness) of the meals. Additional outcomes are individual differences in microstructure of eating, appetite responsiveness, eating Behavior phenotype, interoceptive sensitivity and anthropometry measures. During the trial new technology to capture food intake and eating behavior will be validated which is also an outcome of this trial.

Official Title
-----------------
Opportunities For Food Reformulation: Food Texture and Energy Density Effects on Eating Behaviour and Satiation

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Behavioral: Food properties manipulation to alter eating behavior and food and energy intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18-55 years old at the day of inclusion Able to understand and speak English fluently or without difficulty (self-report) BMI 18.5-30 kg/m2 - measured by the researchers at the end of information meeting Good general health and appetite ( self-report) Commonly (5 out of 7 week days) eating three meals a day every day around approximately the same times(Self-report). Exclusion Criteria: Difficulties with swallowing, chewing and or eating in general Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, respiratory disease or diabetes. Having taste or smell disorders (self-report) Braces (not including a dental wire) or oral piercing Smoking Consuming on average more than 21 glasses of alcohol per week (21) Not willing to stop using drugs during the study period (from inclusion till last test session) Use of medication that may influence study outcomes (self-report) Allergies or intolerance to any ingredient of the test meals or snacks Not willing to eat the test food because of eating habits, believes or religion. Following a vegetarian or vegan diet Lactose intolerant Men having facial hair such as a beard as facial movements cannot be analysed. Followed an energy restricted diet during the last 2 months Gained or lost 5 kg of body weight over the last half year High restrained eater according to the Dutch Eating Behaviour Questionnaire (men: score>2.89, women>3.39 ) Signed up for participating in another research study Employee of Human Nutrition department of Wageningen university Thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition (WUR). Intensive exercising more than 8 hours per week Low score for liking the test foods on a nine point likert scale based on pictures of the food items. Unfamiliar with the test foods (self-report).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The 5 conditions of this study are: low energy density, hard texture (slow eating rate) low energy density, soft texture (fast eating rate) High energy density, hard texture (slow eating rate) High energy density, soft texture (fast eating rate) Average energy density and medium hard texture (control)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low energy density, hard texture<br>Sandwich with a hard texture (slow eating rate) and relatively low energy density (kcal/g) | Behavioral: Food properties manipulation to alter eating behavior and food and energy intake<br>* Food properties of commercially available food products<br>|
| Experimental: low energy density, soft texture<br>Sandwich with a soft texture (fast eating rate) and relatively low energy density (kcal/g) | Behavioral: Food properties manipulation to alter eating behavior and food and energy intake<br>* Food properties of commercially available food products<br>|
| Experimental: High energy density, hard texture<br>Sandwich with a hard texture (slow eating rate) and relatively high energy density (kcal/g) | Behavioral: Food properties manipulation to alter eating behavior and food and energy intake<br>* Food properties of commercially available food products<br>|
| Experimental: High energy density, soft texture<br>Sandwich with a soft texture (fast eating rate) and relatively high energy density (kcal/g) | Behavioral: Food properties manipulation to alter eating behavior and food and energy intake<br>* Food properties of commercially available food products<br>|
| Active Comparator: Average energy density and medium hard texture (control)<br>Sandwich with a medium texture (medium eating rate) and medium energy density (kcal/g) | Behavioral: Food properties manipulation to alter eating behavior and food and energy intake<br>* Food properties of commercially available food products<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake | Intake in Kcal | One meal, up to 30 minutes | 
| Food intake | Intake in gram | One meal, up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating rate | Eating rate gram/min | One meal, up to 30 minutes | 
| chews | number of chews per bite | One meal, up to 30 minutes | 
| bite size | gram/bite | One meal, up to 30 minutes | 
| Energy intake rate | kcal/min | One meal, up to 30 minutes | 
| bites | number of bites per meal | One meal, up to 30 minutes | 
| swallows | number of swallows per meal | One meal, up to 30 minutes | 
| oral exposure time | duration of food in mouth in seconds | One meal, up to 30 minutes | 
| Appetite | subjective ratings of appetite on a 100 mm line scale (visual analogue scale) | One meal, up to 30 minutes | 
| Individual differences in fat free mass (FFM) | % FFM of total body weight | 5 minutes | 
| individual eating rate | eating rate (gram/min) of carrots of each participant (personal trait) | 1 minute | 
| Individual appetite responsiveness | interoceptive sensitivity the ratio between the amount drank till first satiation signal and complete fullness, according to the waterload test | 10 minutes | 
| Sensory properties | rating on a 100mm line scale (visual analogue scale from 0 - not at all to 100 extremely) of the sensory properties of the sandwiches offered during the test sessions | 5 minutes |