OffR: Opportunities for Food Reformulation

Sponsor
Wageningen University (Other)
Overall Status
Completed
CT.gov ID
NCT05659771
Collaborator
4TU pride and prejudice project (Other)
75
1
5
2.5
29.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Food properties manipulation to alter eating behavior and food and energy intake
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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)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 (Participant)
Masking Description:
cover story - different aim
Primary Purpose:
Prevention
Official Title:
Opportunities For Food Reformulation: Food Texture and Energy Density Effects on Eating Behaviour and Satiation
Actual Study Start Date :
Apr 22, 2022
Actual Primary Completion Date :
Jul 8, 2022
Actual Study Completion Date :
Jul 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: low energy density, hard texture

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
Food properties of commercially available food products

Experimental: low energy density, soft texture

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
Food properties of commercially available food products

Experimental: High energy density, hard texture

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
Food properties of commercially available food products

Experimental: High energy density, soft texture

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
Food properties of commercially available food products

Active Comparator: Average energy density and medium hard texture (control)

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
Food properties of commercially available food products

Outcome Measures

Primary Outcome Measures

  1. Energy intake [One meal, up to 30 minutes]

    Intake in Kcal

  2. Food intake [One meal, up to 30 minutes]

    Intake in gram

Secondary Outcome Measures

  1. Eating rate [One meal, up to 30 minutes]

    Eating rate gram/min

  2. chews [One meal, up to 30 minutes]

    number of chews per bite

  3. bite size [One meal, up to 30 minutes]

    gram/bite

  4. Energy intake rate [One meal, up to 30 minutes]

    kcal/min

  5. bites [One meal, up to 30 minutes]

    number of bites per meal

  6. swallows [One meal, up to 30 minutes]

    number of swallows per meal

  7. oral exposure time [One meal, up to 30 minutes]

    duration of food in mouth in seconds

  8. Appetite [One meal, up to 30 minutes]

    subjective ratings of appetite on a 100 mm line scale (visual analogue scale)

  9. Individual differences in fat free mass (FFM) [5 minutes]

    % FFM of total body weight

  10. individual eating rate [1 minute]

    eating rate (gram/min) of carrots of each participant (personal trait)

  11. Individual appetite responsiveness [10 minutes]

    interoceptive sensitivity the ratio between the amount drank till first satiation signal and complete fullness, according to the waterload test

  12. Sensory properties [5 minutes]

    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

Other Outcome Measures

  1. technology to measure intake automatically [One meal, up to 30 minutes]

    automated weighing scales

  2. technology to measure eating behavior [One meal, up to 30 minutes]

    automated measures of eating behavior using video recordings

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wageningen university Wageningen Gelderland Netherlands 6708WE

Sponsors and Collaborators

  • Wageningen University
  • 4TU pride and prejudice project

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marlou Lasschuijt, Assistant Professor, Wageningen University
ClinicalTrials.gov Identifier:
NCT05659771
Other Study ID Numbers:
  • offR WUR
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2022