NCT05071170

Brief Summary

Rationale: Oral processing behaviours (i.e. eating rate, bite size, chews per bite, oral exposure time etc.) play a major role in food ingestion and digestion, and potentially influence satiation and satiety responses . Experimental studies showed that a prolonged mastication or a slower eating rate is associated with decreased food intake , and increased satiety response per kcal consumed. Therefore, one possible approach to control the intake and appetite is to encourage eating behaviour that slow the rate of food intake and enhance the onset of satiety. Texture led changes to oral processing behaviours could 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 in food processing influences food texture characteristics and oral processing behaviours, and subsequently impact on individuals' satiety responses and their subsequent food intake. The proposed study will examine the role of oral processing behaviours and/ or food processing (i.e. minimally processed, processed and ultra-processed) on satiety responses and the subsequent food intake Objectives: The objectives of the study are to characterise the differences in oral processing behaviours (i.e. eating rate, bite size, chew per bite, oral exposure time etc.) and satiety responses of meals that differ in their degree of processing, and to further investigate how texture-based differences in oral processing behaviours modified by degree of food processing influence the satiety responses (fullness over the time) and subsequent food intake. Study design: A total of 1 screening session (Session 1) and 4 test sessions (Sessions 2 to 5) and 2x2 randomised crossover design where participants receive 4 treatments (i.e. 4 test meals) over 4 test sessions Study population: Healthy males ( n=50), aged 21-50 years with BMI between 18-25 kg/m2 Intervention: Session 1 involves tasting of up to 16 food items and computer task to rate and evaluate their perception and health behaviour. Sessions 2 to 5 involve evaluation of sensory characteristics, video recording of participants eating, and wrist-worn accelerometer to track wrist movement while consuming the 4 test meals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

September 7, 2021

Last Update Submit

August 29, 2023

Conditions

Keywords

Eating behaviourEating rateTextureSatietySensory

Outcome Measures

Primary Outcomes (16)

  • Oral processing behaviour

    Participants will be video-recorded during the lunch sessions to measure oral processing behaviour (e.g., derived from number of bites, chews, swallows and eating duration) of the test fixed portion test meals using an annotation software.

    During test session 2, Up to 20 minutes

  • Oral processing behaviour

    Participants will be video-recorded during the lunch sessions to measure oral processing behaviour (e.g., derived from number of bites, chews, swallows and eating duration) of the test fixed portion test meals using an annotation software.

    During test session 3, Up to 20 minutes

  • Oral processing behaviour

    Participants will be video-recorded during the lunch sessions to measure oral processing behaviour (e.g., derived from number of bites, chews, swallows and eating duration) of the test fixed portion test meals using an annotation software.

    During test session 4, Up to 20 minutes

  • Oral processing behaviour

    Participants will be video-recorded during the lunch sessions to measure oral processing behaviour (e.g., derived from number of bites, chews, swallows and eating duration) of the test fixed portion test meals using an annotation software.

    During test session 5, Up to 20 minutes

  • Change in Post breakfast satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 2, at 15 or 30 minutes' intervals, up to 4 hours each

  • Change in Post breakfast satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 3, at 15 or 30 minutes' intervals, up to 4 hours each

  • Change in Post breakfast satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 4, at 15 or 30 minutes' intervals, up to 4 hours each

  • Change in Post breakfast satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 5, at 15 or 30 minutes' intervals, up to 4 hours each

  • Change in Post lunch satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 2, 15 or 30 minutes' intervals, up to 2 hours each

  • Change in Post lunch satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 3, 15 or 30 minutes' intervals, up to 2 hours each

  • Change in Post lunch satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 4, 15 or 30 minutes' intervals, up to 2 hours each

  • Change in Post lunch satiety responses Session 5

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

    During test session 5, 15 or 30 minutes' intervals, up to 2 hours each

  • Subsequent food intake post test meal

    Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants' calorie intake for the remaining day on the test session.

    During test session 2, up to 0000hrs

  • Subsequent food intake post test meal

    Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants' calorie intake for the remaining day on the test session.

    During test session 3, up to 0000hrs

  • Subsequent food intake post test meal

    Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants' calorie intake for the remaining day on the test session.

    During test session 4, up to 0000hrs

  • Subsequent food intake post test meal

    Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants' calorie intake for the remaining day on the test session.

    During test session 5, up to 0000hrs

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 post meal satiety and subsequent post meal energy intake according to degree of food processing and eating behaviour

Degree of food processing and food texture

Eligibility Criteria

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

Study population will be recruited from the National University of Singapore via advertisements posted in public notice boards at the campus, local food shops and cafes, and approved websites.Potential study participants will also be recruited from existing database of previous study participants who have provided permission to be contacted for participants in future research projects. Word of mouth and email will also be used to recruit potential participants.

You may qualify if:

  • Healthy male
  • 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:

  • Are a smoker
  • Have any 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 colourings 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.)
  • Have sinus problems that affect your taste and smell
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Are 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)
  • Are a 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
  • Are 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

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Pey Sze Teo, PhD

    Singapore Institute Of Food and Biotechnology Innovation (SIFBI), A*STAR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

October 8, 2021

Study Start

May 5, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations