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AdultsNCT04589221

Sensory and Oral Processing Characteristics of Commonly Consumed Foods

An observational study of Adults, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 50 years
Conditions the study is for
Adults
What is being tested?
Ad libitum energy intake
How many people
78 participants
Where
1 siteSingapore
Study dates
2 Nov 2020to 30 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Adult

Study population: General public of Singapore aged between 21 to 50 years old.

Who may be able to join

  • Healthy male or female
  • Aged between 21 and 50-year-old
  • Are of normal weight (BMI 18-25kg/m2)
  • Stable weight for the previous 12 months (<5kg weight fluctuation in the previous year)
  • Healthy dentition and ability to bite, chew and swallow normally
  • No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding
  • No caries or periodontal disease

Who cannot join

  • Smoker
  • Currently pregnant or in lactating
  • Dislikes, intolerances or allergies to foods or common food ingredients e.g. nuts, soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colouring or flavourings (e.g. MSG), etc.
  • Have any specific dietary requirements and/ or restrictions (e.g. Vegan/ vegetarian, religious beliefs, lactose intolerance, calorie restricted diet etc.)
  • Sinus problems that affect your taste and smell
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Show all 12Show fewer
  • Taking insulin or medication known to affect your appetite or metabolism
  • Have major chronic diseases such as heart disease, cancer or diabetes mellitus
  • Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
  • Member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Singapore Institute of Food and Biotechnology Innovation (SIFBI)/Clinical Nutrition Research Centre

    Singapore, 117599

Other trials in Singapore

About this study

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.

Read more

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.

Read the detailed 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.

Conditions
Adults
Being tested
Ad libitum energy intake
Keywords
Eating behaviour, Eating rate, Texture, Sensory
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad libitum energy intakeBehavioural

    Investigate ad libitum energy intake according to degree of food processing and eating behaviour

Study groups in NCT04589221
Study groupRoleWhat they receive
Degree of food processing and food textureProcessed vs unprocessed foods based on NOVA classification Soft and hard foods manipulated by cooking method
Receives: Behavioral: Ad libitum energy intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral processing behaviour

    Participants will be video-recorded to measure oral processing behaviour of the test foods

    Measured: Part 1, during the 3 test sessions, up to 1 hour each

  2. Ad libitum energy intake

    Test foods consumed during test sessions by the participants will be recorded.

    Participants will be asked to bring a food dairy home for recording their food and beverage intake for the rest of the test day.

    Measured: Part 2, during the 4 test sessions, up to 2 hours each

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start2 Nov 2020
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589221
Sponsor's protocol ID
2019-084
Status last verified
Dec 2021
First submitted
7 Oct 2020
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teo PS, Lim AJ, Goh AT, R J, Choy JYM, McCrickerd K, Forde CG. Texture-based differences in eating rate influence energy intake for minimally processed and ultra-processed meals. Am J Clin Nutr. 2022 Jul 6;116(1):244-254. doi: 10.1093/ajcn/nqac068.

    PubMed 35285882

Questions about this trial

What is this clinical trial studying?

An observational study of Adults, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral processing behaviour (time frame: Part 1, during the 3 test sessions, up to 1 hour each). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04589221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

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