NCT04589221

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

October 7, 2020

Last Update Submit

December 13, 2021

Conditions

Keywords

Eating behaviourEating rateTextureSensory

Outcome Measures

Primary Outcomes (2)

  • Oral processing behaviour

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

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

  • 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.

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

Study Arms (1)

Degree of food processing and food texture

Processed vs unprocessed foods based on NOVA classification Soft and hard foods manipulated by cooking method

Behavioral: Ad libitum energy intake

Interventions

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

Degree of food processing and food texture

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Singapore, 117599, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Pey Sze Teo, PhD

    Teo_Pey_Sze@sifbi.a-star.edu.sg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Principal Investigator

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 19, 2020

Study Start

November 2, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations