SatiationNCT02977260
The Lunch Study: the Combined Effects of Food Texture and Energy Density on Intake
A study testing Thin/Low Energy, Thin/High Energy and Thick/Low Energy in people with Satiation, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
Meal size is strongly influenced by a number of external features of the food environment which can promote over-consumption, such as the availability of palatable energy dense foods. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiation
- What is being tested?
- Thin/Low Energy, Thin/High Energy and Thick/Low Energy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 21 and 50 years
- BMI < 30 kg/m2
Who cannot join
- Individuals whose body weight has changed more than 5 kilograms in the last 12 months
- People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
- Individuals who are currently dieting
- People with intolerances or allergies to study foods or test products, e.g. soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings, etc
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Meal size is strongly influenced by a number of external features of the food environment which can promote over-consumption, such as the availability of palatable energy dense foods. The current research aimed to investigate whether natural food-based differences in texture could be used to slow down eating rate and reduce intake from large portions and higher energy dense foods.
A four-session randomised crossover study assessed the effect of faster vs. slower eating rate, achieved through manipulating food texture, on ad-libitum consumption (weight and calories) at a meal, alone and in combination with variations in meal energy-density (higher vs. lower)
Read the detailed description
The current obesogenic environment is characterized by the abundance of palatable and high energy dense foods. High dietary energy density can promote sustained overcompensation at meal times. On the other hand, eating at a slower rate has been shown to reduce meal size, and food-based texture differences can slow eating rate. It is possible that texture-based differences in eating rate could be used to reduce energy intake in of foods that are higher in energy density.
This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum consumption of a meal, alone and in combination with variations in meal energy-density (0.57 kcal/g vs 1.01 kcal/g). The meal combinations were as follows:
Meal 1: thin/0.57 kcal; Meal 2: thin/1.01 kcal/g; Meal 3: thick/ 0.57 kcal/g; Meal 4: thick /1.01 kcal/g
Participants consumed the four test meals over four non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. Each part followed a completely randomised full crossover design.
The primary objective was to assess ad libitum intake (both kcal and g) of the test meals, depending on the combination of food texture and energy density.
The secondary objectives were to assess the eating rate, oral processing characteristics, changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the rest of the test day (food diary), as a function of the test meal texture and energy density
- Conditions
- Satiation
- Being tested
- Thin/Low Energy, Thin/High Energy, Thick/Low Energy, Thick/High Energy
- Keywords
- Meal size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin/Low EnergyOther
Thin textured rice meal (ground rice grains) with lower energy density (0.57 kcal/g)
Thin/High EnergyOther
Thin textured rice meal (ground rice grains) with higher energy density (1.01 kcal/g)
Thick/Low EnergyOther
Thicker textured rice meal (whole rice grains) with lower energy density (0.57 kcal/g)
Thick/High EnergyOther
Thicker textured rice meal (whole rice grains) and high energy density (1.01 kcal/g)
| Study group | Role | What they receive |
|---|---|---|
| Test Meal 1 | Experimental | Thin/Low Energy Receives: Other: Thin/Low Energy |
| Test Meal 2 | Experimental | Thin/High Energy Receives: Other: Thin/High Energy |
| Test Meal 3 | Experimental | Thick/Low Energy Receives: Other: Thick/Low Energy |
| Test Meal 4 | Experimental | Thick/High Energy Receives: Other: Thick/High Energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum intake of the test meals - weight (g)
The weight of the test meal consumed during the test session was measured.
There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.
Measured: Measured once for up to 20 minutes
Ad libitum intake of the test meals - calories (kcal)
The weight of the meal consumed was measured and convert to calories using the meal energy density (which is known).
There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.
Measured: Measured once for up to 20 minutes
Secondary outcomes (3)
Eating rate of the test meals
Video recordings of the participants eating are coded and from this eating rate was calculated as grams consumed per minute (g/min).
Measured: Measured once for up to 20 minutes
Changes in rated appetite pre- to post meal consumption and up to 90 minutes post-consumption
100-point Visual Analogue Scale (VAS) ratings of hunger, fullness, desire to eat, prospective consumption and thirst
Measured: pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes
Energy intake (kcal) for the rest of the test day recorded in a Food diary
Food intake recorded in a food diary
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Keri McCrickerd, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- Keri McCrickerd, PhD, Principal investigator, Clinical Nutrition Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977260
- Sponsor's protocol ID
- 2015/00867 Part 1
- Other IDs
- 2015
- Status last verified
- Nov 2016
- First submitted
- 21 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lunch Study: the Combined Effects of Food Texture and Energy Density on Intake
- ClinicalTrials.gov ID
- NCT02977260
- Acronym / sponsor ID
- 2015/00867 Part 1
- Conditions
- Satiation
- Keywords
- Meal size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Meal size is strongly influenced by a number of external features of the food environment which can promote over-consumption, such as the availability of palatable energy dense foods. The current research aimed to investigate whether natural food-based differences in texture could be used to slow down eating rate and reduce intake from large portions and higher energy dense foods.
A four-session randomised crossover study assessed the effect of faster vs. slower eating rate, achieved through manipulating food texture, on ad-libitum consumption (weight and calories) at a meal, alone and in combination with variations in meal energy-density (higher vs. lower)
Detailed description
The current obesogenic environment is characterized by the abundance of palatable and high energy dense foods. High dietary energy density can promote sustained overcompensation at meal times. On the other hand, eating at a slower rate has been shown to reduce meal size, and food-based texture differences can slow eating rate. It is possible that texture-based differences in eating rate could be used to reduce energy intake in of foods that are higher in energy density.
This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum consumption of a meal, alone and in combination with variations in meal energy-density (0.57 kcal/g vs 1.01 kcal/g). The meal combinations were as follows:
Meal 1: thin/0.57 kcal; Meal 2: thin/1.01 kcal/g; Meal 3: thick/ 0.57 kcal/g; Meal 4: thick /1.01 kcal/g
Participants consumed the four test meals over four non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. Each part followed a completely randomised full crossover design.
The primary objective was to assess ad libitum intake (both kcal and g) of the test meals, depending on the combination of food texture and energy density.
The secondary objectives were to assess the eating rate, oral processing characteristics, changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the rest of the test day (food diary), as a function of the test meal texture and energy density
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Meal 1 | Experimental | Other: Thin/Low EnergyThin/Low Energy |
| Test Meal 2 | Experimental | Other: Thin/High EnergyThin/High Energy |
| Test Meal 3 | Experimental | Other: Thick/Low EnergyThick/Low Energy |
| Test Meal 4 | Experimental | Other: Thick/High EnergyThick/High Energy |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 21 and 50 years
- BMI < 30 kg/m2
Key exclusion criteria (5 listed)
- Individuals whose body weight has changed more than 5 kilograms in the last 12 months
- People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
- Individuals who are currently dieting
- People with intolerances or allergies to study foods or test products, e.g. soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings, etc
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thin/Low EnergyThin textured rice meal (ground rice grains) with lower energy density (0.57 kcal/g) | Other | Test Meal 1 |
| Thin/High EnergyThin textured rice meal (ground rice grains) with higher energy density (1.01 kcal/g) | Other | Test Meal 2 |
| Thick/Low EnergyThicker textured rice meal (whole rice grains) with lower energy density (0.57 kcal/g) | Other | Test Meal 3 |
| Thick/High EnergyThicker textured rice meal (whole rice grains) and high energy density (1.01 kcal/g) | Other | Test Meal 4 |
Primary outcome
Ad libitum intake of the test meals - weight (g)
Time frame: Measured once for up to 20 minutes
The weight of the test meal consumed during the test session was measured. There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.
Ad libitum intake of the test meals - calories (kcal)
Time frame: Measured once for up to 20 minutes
The weight of the meal consumed was measured and convert to calories using the meal energy density (which is known). There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.
3 secondary outcomes
Eating rate of the test meals
Time frame: Measured once for up to 20 minutes
Changes in rated appetite pre- to post meal consumption and up to 90 minutes post-consumption
Time frame: pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes
Energy intake (kcal) for the rest of the test day recorded in a Food diary
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Satiation
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Cerebellar TMS and Satiety in Prader-Willi Syndrome
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Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keri McCrickerd, PhD principal investigator
Clinical Nutrition Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thin/Low Energy, Thin/High Energy and Thick/Low Energy in people with Satiation, 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 2 inclusion and 5 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 30 Nov 2016. 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?
Ad libitum intake of the test meals - weight (g) (time frame: Measured once for up to 20 minutes). 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?
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 30 Nov 2016.