Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04589221 |
| Other study ID # |
2019-084 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2020 |
| Est. completion date |
August 30, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Clinical Nutrition Research Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Rationale: Oral processing behaviours (i.e. eating rate, bite size, chews per bite) play an
important role in the onset of satiation and satiety and laboratory studies have shown that
people who eat quickly consume more energy during an ad libitum meal. Therefore, one possible
approach to control the energy intake is to encourage eating behaviour that slow the rate of
calorie intake of the meal. Numerous studies that use external cues and prompts to change the
eating rate (e.g. utensil, devices) have shown to produce clinically meaningful results.
However, the long-term efficacy of these external manipulation to eating rate remains unclear
and have difficulties in adherence. Texture led changes to oral processing behaviours
therefore offer an exciting opportunity to adapt an individual's response to structure
properties of the food being consumed in a way that maintains the associated eating
experience and satiety from food intake.
However, no studies to date have investigated how differences food processing influence food
texture characteristics and oral processing behaviour and the subsequent impact on energy
intake for commonly consumed meals. The proposed study will explore the impact of food
texture and oral processing characteristics on energy intake for the minimally-processed and
ultra-processed foods or meals, to explore the impact of food processing on texture, oral
processing and energy intakes.
Objective: The objectives of the study are to characterise the differences in sensory
perception, and oral processing behaviours (i.e. eating rate, bite size, chew per bite, oral
exposure time etc.) of foods and meals that differ in their degree of processing (Part 1),
and to further investigate how texture-based differences in oral processing behaviour
influence ad-libitum energy intake (Part 2). This study is also aimed to see how is the
texture-based differences in oral processing behaviour modified by degree of food processing
(i.e. un-, minimally-processed, processed and ultra-processed foods) (Part 2).
Study design: Part 1) Randomised non-blinded feeding trial where participants taste up to 48
food items over 3 test sessions; Part 2) 2x2 randomised crossover design where participants
receive 4 treatments (i.e. 4 test meals) over 4 test sessions
Study population: Healthy females and males (n=30 for Part 1; n=50 for Part 2) aged 21-50
years with BMI between 18-25 kg/m2
Intervention: Part 1) Participants will taste and evaluate up to 48 food items over 3
sessions in randomised order. Session 1 involves tasting of up to 16 food items and computer
task to rate and evaluate their perception and health behaviour. Sessions 2-4 involve
evaluation of sensory characteristics, video-recordings of participants eating, and wrist
worn accelerometer to track wrist movement while tasting up to 48 food items.
Description:
Objectives:
The objectives of the study are to characterise the differences in sensory perception, and
oral processing behaviours (i.e. eating rate, bite size, chew per bite, oral exposure time
etc.) of foods and meals that differ in their degree of processing, and to further
investigate how texture-based differences in oral processing behaviour influence ad-libitum
energy intake. In addition, this study is also aimed to see how is the texture-based
differences in oral processing behaviour modified by degree of food processing (i.e. un-,
minimally-processed, processed and ultra-processed foods).
Study Design:
The study involves 2 parts. A maximum of 30 participants will be recruited to complete Part 1
(1 screening session & 3 test sessions); and a maximum of 50 participants will be recruited
to completed Part 2 (4 test sessions) of the study.
Part 1) Sensory perception and health behaviour for foods varying in degree of processing and
nutrient source will be evaluated using a Health Behaviour Questionnaire and food perception
and health behaviour task. Perceived sensory and oral processing behaviour differences
between a series of commercially available and commonly consumed foods (e.g. carrot, apple,
meatball, etc.) will be assessed using sensory descriptive analysis on 100mm Visual Analogue
Scale (VAS), and video recording, respectively.
Part 2) In addition, the sensory and oral processing behaviour, satiety and ad-libitum energy
intake across different meals (e.g. rice with meat and vegetable, meat with potato and salad,
etc.) will be assessed using video recording, sensory and appetite assessment on 100mm VAS,
and a weighing food balance.
The current study will require participants to attend either 4.5 hours (Screening and Part
1), 9.5 hours (Screening and Part 2) or 12.5 hours (Screening, Parts 1 and 2). All
participants will be required to join for one-time screening prior to the study. Participants
will require to fast for three-hour (Part 1) and at least one hour (Part 2) before their
scheduled lunch-time test sessions. Each session will last for approximately one hour
(Screening, Part 1), or two hours (Part 2), as indicated accordingly.
In the situation of participant dropout, the data that have been collected until the time of
withdrawal will be kept and analysed. The reason is to enable a complete and comprehensive
evaluation of the study.
Test Foods:
Part 1) Commercially available and commonly consumed foods (e.g. carrot, apple, meatball,
etc.) Part 2) Consist of components previously tested in Part 1 and comprise foods that are
commercially available, safe for human consumption and prepared in line with safe hygienic
food preparation (e.g. rice with meat and vegetable, meat with potato and salad, etc.)
Screening (Session 1, 1- 1.5 hour):
All potential participants will be asked to give informed consent before taking part in any
of the research activities. Participants are to complete a screening questionnaire and to
taste five different basic taste solutions (sweet [sucrose, 3.2-100 mmol/L], salty [sodium
chloride, 3.2-100 mmol/L], bitter [caffeine, 0.25-0.79 mmol/L], sour [citric acid, 0.63-5
mmol/L] and umami[monosodium glutamate, 1-31.6 mmol/L]) to assess their taste discrimination
ability. Basic anthropometric measurements such as height, weight, skinfold measurements and
percentage body fat using a Bioelectrical Impedance Analyser will be taken.
Successfully screened participants will proceed to complete a Health Behaviour Questionnaire
and taste no more than 16 samples to rate and evaluate their perception and health behaviour
for the foods varying in degree of processing and nutrient sources at the remaining of the
screening session.
Part 1 (3 test sessions, 1 hour each):
Sensory and oral processing behaviour of commercially available food samples will be
assessed. A maximum of 30 participants will be recruited for this part of the study.
Participants will taste no more than 16 samples in each session.
Participants will be asked to taste each food sample and evaluate on liking, familiarity and
the sensory attributes such as overall flavour intensity, firmness, crunchiness, chewiness,
saltiness and sweetness. A mandatory inter-stimulus break of one minute will be enforced
between each sample to reduce possible fatigue and allow time to cleanse your palate with
water and crackers provided. All evaluations will be administrated and collected using a
computer. Participants will also be video-recorded during the sessions for collection of oral
processing data (i.e. eating rate, bite number, bite size etc). In addition, Participants
will be asked to wear a wrist worn accelerometer (M5StickC ESP32-PICO Mini loT Development
Kit, China) on the hand they eat with to track the wrist movement while eating.
Part 2 (4 test sessions, 2 hour each):
The sensory, oral processing characteristics and ad libitum energy intake for different meals
will be assessed in this part. A maximum of 50 participants will be recruited for this part
of the study. Participants who completed Part 1 will be invited to join the Part 2, however
the participation is not mandatory. Participants will attend 1 session per week for four
consecutive weeks to evaluate up to 4 ad libitum test meal across for lunch-time sessions,
i.e. 1 ad libitum test meal per session.
Participant will be required to fast from 11.00 pm the evening before and refrain from
engaging in vigorous physical activities.
On each test day, participants will be asked to arrive at CNRC between 8.00-9.00am and
complete a set of appetite ratings disguised as "Mood Questions" (pre-breakfast rating).
Following the pre-breakfast rating, participants will receive a standardised, fixed portion
breakfast and mid-morning drink/snack to take away with them and consume at fixed intervals
during the morning (before the lunch). The purpose is to equilibrate their appetite need
state ahead of the ad-libitum test meal at lunch session.
Participants will consume the breakfast within 15 minutes, after which complete a second set
of appetite ratings (post-breakfast ratings). Participants will refrain from consuming
anything except water and continue to complete the appetite rating at 15 or 30 minutes'
intervals, prompted with reminder set on their mobile device.
After approximately 2 hours, participants will consume the mid-morning drink/ snack within 15
minutes. Participants will then continue to rate their appetite at 15 minute intervals before
coming to CNRC for their lunch.
The lunch session will be scheduled from midday onwards and will begin with a set of appetite
rating (pre-lunch rating). Participants will be served an ad libitum test meal (~800g to
1000g) along with a glass of water, and instructed to taste a mouthful of the meal and rate
its sensory characteristics. Participants will then be asked to consume the ad libitum test
meal in their normal way and to eat until comfortably full. Participants' eating behaviour at
lunch will be recorded in order to analyse and behaviourally code their oral processing
behaviour (i.e. eating rate, bite number, bite size etc). In addition, Participants will be
asked to wear a wrist worn accelerometer on the hand they eat with to track the wrist
movement while eating. After completed eating, participants will be required to complete
post-lunch appetite ratings at 15minutes interval for 90minutes, and bring a food diary home
for recording their food and beverage intake for the rest of the test day.
