Opportunities for Food Reformulation

Overweight and Obesity Clinical Trial

— OffR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659771
• Other study ID #: offR WUR
• Status: Completed
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: July 8, 2022

Study information

• Verified date: December 2022
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Food properties manipulation to alter eating behavior and food and energy intake
Food properties of commercially available food products

Locations

Country	Name	City	State
Netherlands	Wageningen university	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	4TU pride and prejudice project

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	technology to measure intake automatically	automated weighing scales	One meal, up to 30 minutes
Other	technology to measure eating behavior	automated measures of eating behavior using video recordings	One meal, up to 30 minutes
Primary	Energy intake	Intake in Kcal	One meal, up to 30 minutes
Primary	Food intake	Intake in gram	One meal, up to 30 minutes
Secondary	Eating rate	Eating rate gram/min	One meal, up to 30 minutes
Secondary	chews	number of chews per bite	One meal, up to 30 minutes
Secondary	bite size	gram/bite	One meal, up to 30 minutes
Secondary	Energy intake rate	kcal/min	One meal, up to 30 minutes
Secondary	bites	number of bites per meal	One meal, up to 30 minutes
Secondary	swallows	number of swallows per meal	One meal, up to 30 minutes
Secondary	oral exposure time	duration of food in mouth in seconds	One meal, up to 30 minutes
Secondary	Appetite	subjective ratings of appetite on a 100 mm line scale (visual analogue scale)	One meal, up to 30 minutes
Secondary	Individual differences in fat free mass (FFM)	% FFM of total body weight	5 minutes
Secondary	individual eating rate	eating rate (gram/min) of carrots of each participant (personal trait)	1 minute
Secondary	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
Secondary	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