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Opportunities for Food Reformulation (OffR)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Food properties manipulation to alter eating behavior and food and energy intake
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Wageningen university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

low energy density, hard texture

low energy density, soft texture

High energy density, hard texture

High energy density, soft texture

Average energy density and medium hard texture (control)

Arm Description

Sandwich with a hard texture (slow eating rate) and relatively low energy density (kcal/g)

Sandwich with a soft texture (fast eating rate) and relatively low energy density (kcal/g)

Sandwich with a hard texture (slow eating rate) and relatively high energy density (kcal/g)

Sandwich with a soft texture (fast eating rate) and relatively high energy density (kcal/g)

Sandwich with a medium texture (medium eating rate) and medium energy density (kcal/g)

Outcomes

Primary Outcome Measures

Energy intake
Intake in Kcal
Food intake
Intake in gram

Secondary Outcome Measures

Eating rate
Eating rate gram/min
chews
number of chews per bite
bite size
gram/bite
Energy intake rate
kcal/min
bites
number of bites per meal
swallows
number of swallows per meal
oral exposure time
duration of food in mouth in seconds
Appetite
subjective ratings of appetite on a 100 mm line scale (visual analogue scale)
Individual differences in fat free mass (FFM)
% FFM of total body weight
individual eating rate
eating rate (gram/min) of carrots of each participant (personal trait)
Individual appetite responsiveness
interoceptive sensitivity the ratio between the amount drank till first satiation signal and complete fullness, according to the waterload test
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

Full Information

First Posted
May 2, 2022
Last Updated
December 12, 2022
Sponsor
Wageningen University
Collaborators
4TU pride and prejudice project
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1. Study Identification

Unique Protocol Identification Number
NCT05659771
Brief Title
Opportunities for Food Reformulation
Acronym
OffR
Official Title
Opportunities For Food Reformulation: Food Texture and Energy Density Effects on Eating Behaviour and Satiation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University
Collaborators
4TU pride and prejudice project

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
cover story - different aim
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low energy density, hard texture
Arm Type
Experimental
Arm Description
Sandwich with a hard texture (slow eating rate) and relatively low energy density (kcal/g)
Arm Title
low energy density, soft texture
Arm Type
Experimental
Arm Description
Sandwich with a soft texture (fast eating rate) and relatively low energy density (kcal/g)
Arm Title
High energy density, hard texture
Arm Type
Experimental
Arm Description
Sandwich with a hard texture (slow eating rate) and relatively high energy density (kcal/g)
Arm Title
High energy density, soft texture
Arm Type
Experimental
Arm Description
Sandwich with a soft texture (fast eating rate) and relatively high energy density (kcal/g)
Arm Title
Average energy density and medium hard texture (control)
Arm Type
Active Comparator
Arm Description
Sandwich with a medium texture (medium eating rate) and medium energy density (kcal/g)
Intervention Type
Behavioral
Intervention Name(s)
Food properties manipulation to alter eating behavior and food and energy intake
Intervention Description
Food properties of commercially available food products
Primary Outcome Measure Information:
Title
Energy intake
Description
Intake in Kcal
Time Frame
One meal, up to 30 minutes
Title
Food intake
Description
Intake in gram
Time Frame
One meal, up to 30 minutes
Secondary Outcome Measure Information:
Title
Eating rate
Description
Eating rate gram/min
Time Frame
One meal, up to 30 minutes
Title
chews
Description
number of chews per bite
Time Frame
One meal, up to 30 minutes
Title
bite size
Description
gram/bite
Time Frame
One meal, up to 30 minutes
Title
Energy intake rate
Description
kcal/min
Time Frame
One meal, up to 30 minutes
Title
bites
Description
number of bites per meal
Time Frame
One meal, up to 30 minutes
Title
swallows
Description
number of swallows per meal
Time Frame
One meal, up to 30 minutes
Title
oral exposure time
Description
duration of food in mouth in seconds
Time Frame
One meal, up to 30 minutes
Title
Appetite
Description
subjective ratings of appetite on a 100 mm line scale (visual analogue scale)
Time Frame
One meal, up to 30 minutes
Title
Individual differences in fat free mass (FFM)
Description
% FFM of total body weight
Time Frame
5 minutes
Title
individual eating rate
Description
eating rate (gram/min) of carrots of each participant (personal trait)
Time Frame
1 minute
Title
Individual appetite responsiveness
Description
interoceptive sensitivity the ratio between the amount drank till first satiation signal and complete fullness, according to the waterload test
Time Frame
10 minutes
Title
Sensory properties
Description
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
Time Frame
5 minutes
Other Pre-specified Outcome Measures:
Title
technology to measure intake automatically
Description
automated weighing scales
Time Frame
One meal, up to 30 minutes
Title
technology to measure eating behavior
Description
automated measures of eating behavior using video recordings
Time Frame
One meal, up to 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Wageningen university
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708WE
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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