Markedly Reduced Food IntakeNCT04138862
The Reduced Calorie Food and Mood Study
A study testing Product Labelling and Sensory modifications in people with Markedly Reduced Food Intake and Satiety and Food Intake, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
Health- and nutrient-related labelling is often used to draw consumer's attention to the potential benefits of consuming one product over another. However, research suggests that products believed to be 'healthier' and/or lower calorie are often experienced as less satiating, and may actually prompt people to consume… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Markedly Reduced Food Intake, Satiety and Food Intake
- What is being tested?
- Product Labelling and Sensory modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Sep 2017to 20 Sep 2019
- 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
- English Speaking
Who cannot join
- People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
- Individuals who are currently following a diet program
- 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
- Regular smokers (> 5 cigarettes per week)
- Individuals with body mass index (BMI) < 18.5 and > 30.0 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reduced Calorie Food and Mood Study: Using Sensory Cues to Optimise the Satiety Value of a Reduced-calorie 'Healthier Choice' Product
Health- and nutrient-related labelling is often used to draw consumer's attention to the potential benefits of consuming one product over another. However, research suggests that products believed to be 'healthier' and/or lower calorie are often experienced as less satiating, and may actually prompt people to consume more or these foods, or others.
The current research aimed to whether consuming a reduced-calorie product labelled "Healthier Choice" affects compensatory eating behaviour (relative to an unlabelled product), and the extent to which this depends on the product's sensory characteristics.
A two-session randomised study was used to test the satiety value of a reduced-calorie beverage - characterised as changes in rated appetite and later food intake (kcal) relative to an original-calorie version - consumed in one of four contexts varying in label and sensory cues. The beverage-contexts were assessed in a non-crossover manner.
Read the detailed description
Reformulation strategies to reduce the energy density of commonly consumed food and beverage products are needed to support weight management, but one concern is that awareness of consuming 'healthier' foods can promote compensatory eating behaviours. An alternative solution is not to label calorie-reductions so consumers are unaware that they are consuming fewer calories in reformulated products, which has been described as a 'stealth health' approach.
This study investigated whether consuming a reduced-calorie product labelled with Singapore's 'Healthier Choice Symbol' impacts its satiating power relative to an unlabelled control, and the extent to which this can be further modified by changes to the product's sensory characteristics.
Participants were randomised to consume an original (211 kcal per portion; kcal/g) and reduced calorie (98 kcal per portion; kcal/g) versions of a soymilk, with the reduced calorie version presented in one of four beverage context conditions:
- Context 1 - Sensory-matched, unlabelled calorie reduction (control) - Sensory matched to taste like the original (equally sweet, thick and creamy), without a label identifier (covert energy reduction).
- Context 2 - Sensory-matched, labelled calorie reduction - The same sensory matched beverage as above, but with the HCS attached (explicit energy reduction).
- Context 3 - Sensory-reduced, labelled calorie reduction - Designed to taste less thick, sweet and creamy than the original, with the HCS attached (explicit energy reduction).
- Context 4 - Sensory-enhanced, labelled calorie reduction - Designed to taste thicker, creamier and sweeter than the original, with the HCS attached (explicit energy reduction).
Participants consumed the two beverages (original vs. reduced energy) in one of the four beverage contexts on two non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. The calorie reduction was conducted as full-crossover while the beverage context groups were assigned non-crossover, to reduce demand awareness.
The primary objective was to assess changes in lunch energy intake (kcal) after consuming the original and reduced-calorie beverages, depending on the beverage context the reduced calorie version was presented in.
The secondary objectives were to assess the sensory evaluations of the beverages (liking and perceived thickness, sweetness and expected fullness etc.), changes in rated appetite up to 180 minutes post-consumption and energy intake (kcal) for the rest of the test day (recorded in a food diary), as a function of the beverages energy density and context.
- Being tested
- Product Labelling and Sensory modifications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product Labelling and Sensory modificationsBehavioural
the beverages varied in the label that was attached (no label or a 'Healthier Choice' label) and the sensory matching of the calorie reduction (sensory matched, reduced or enhanced).
| Study group | Role | What they receive |
|---|---|---|
| Sensory Matched/Unlabelled | Active comparator | Sensory-matched covert calorie reduction, unlabelled Receives: Behavioral: Product Labelling and Sensory modifications |
| Sensory Matched/Labelled | Experimental | Sensory-matched explicit calorie reduction, labelled Receives: Behavioral: Product Labelling and Sensory modifications |
| Sensory Reduced/Labelled | Experimental | Sensory-reduced explicit calorie reduction, labelled Receives: Behavioral: Product Labelling and Sensory modifications |
| Sensory Enhanced/Labelled | Experimental | Sensory-enhanced explicit calorie reduction, labelled Receives: Behavioral: Product Labelling and Sensory modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum intake of a later lunch meal (calories - kcal)
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
Secondary outcomes (3)
Changes in rated appetite pre- to post beverage and up to 180 minutes post-consumption, all prior to consuming an ad libitum lunch
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, + 120 mins, + 150 mins + 180 mins
Sensory ratings after the first sip of the test beverage
100-point Visual Analogue Scale (VAS) ratings of thick, sweet, liking, creamy, chalky and sour.
Measured: Measured once upon first tasting the test beverage for up to 5 minute
Energy intake (kcal) for across the test day recorded in a Food diary
Food intake recorded in a food diary and analysed by a trained research assistant using FoodWorks 8.0.3553.
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 posted25 Oct 2019
- Study start9 Sep 2017
- Primary completion9 Sep 2018
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Markedly Reduced Food IntakeStudies 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
- Factorial
- Model description
- Mixed Design: 4 x Beverage Contexts (assessed in parallel to reduce demand awareness) 2 x Energy Density (assessed as full crossover)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 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
- NCT04138862
- Sponsor's protocol ID
- 2017/01013
- Other IDs
- 2017
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reduced Calorie Food and Mood Study: Using Sensory Cues to Optimise the Satiety Value of a Reduced-calorie 'Healthier Choice' Product
- ClinicalTrials.gov ID
- NCT04138862
- Acronym / sponsor ID
- 2017/01013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 25 Oct 2019 (actual)
- 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.
Health- and nutrient-related labelling is often used to draw consumer's attention to the potential benefits of consuming one product over another. However, research suggests that products believed to be 'healthier' and/or lower calorie are often experienced as less satiating, and may actually prompt people to consume more or these foods, or others.
The current research aimed to whether consuming a reduced-calorie product labelled "Healthier Choice" affects compensatory eating behaviour (relative to an unlabelled product), and the extent to which this depends on the product's sensory characteristics.
A two-session randomised study was used to test the satiety value of a reduced-calorie beverage - characterised as changes in rated appetite and later food intake (kcal) relative to an original-calorie version - consumed in one of four contexts varying in label and sensory cues. The beverage-contexts were assessed in a non-crossover manner.
Detailed description
Reformulation strategies to reduce the energy density of commonly consumed food and beverage products are needed to support weight management, but one concern is that awareness of consuming 'healthier' foods can promote compensatory eating behaviours. An alternative solution is not to label calorie-reductions so consumers are unaware that they are consuming fewer calories in reformulated products, which has been described as a 'stealth health' approach.
This study investigated whether consuming a reduced-calorie product labelled with Singapore's 'Healthier Choice Symbol' impacts its satiating power relative to an unlabelled control, and the extent to which this can be further modified by changes to the product's sensory characteristics.
Participants were randomised to consume an original (211 kcal per portion; kcal/g) and reduced calorie (98 kcal per portion; kcal/g) versions of a soymilk, with the reduced calorie version presented in one of four beverage context conditions:
- Context 1 - Sensory-matched, unlabelled calorie reduction (control) - Sensory matched to taste like the original (equally sweet, thick and creamy), without a label identifier (covert energy reduction).
- Context 2 - Sensory-matched, labelled calorie reduction - The same sensory matched beverage as above, but with the HCS attached (explicit energy reduction).
- Context 3 - Sensory-reduced, labelled calorie reduction - Designed to taste less thick, sweet and creamy than the original, with the HCS attached (explicit energy reduction).
- Context 4 - Sensory-enhanced, labelled calorie reduction - Designed to taste thicker, creamier and sweeter than the original, with the HCS attached (explicit energy reduction).
Participants consumed the two beverages (original vs. reduced energy) in one of the four beverage contexts on two non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. The calorie reduction was conducted as full-crossover while the beverage context groups were assigned non-crossover, to reduce demand awareness.
The primary objective was to assess changes in lunch energy intake (kcal) after consuming the original and reduced-calorie beverages, depending on the beverage context the reduced calorie version was presented in.
The secondary objectives were to assess the sensory evaluations of the beverages (liking and perceived thickness, sweetness and expected fullness etc.), changes in rated appetite up to 180 minutes post-consumption and energy intake (kcal) for the rest of the test day (recorded in a food diary), as a function of the beverages energy density and context.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Mixed Design: 4 x Beverage Contexts (assessed in parallel to reduce demand awareness) 2 x Energy Density (assessed as full crossover)
| Arm | Type | Receives |
|---|---|---|
| Sensory Matched/Unlabelled | Active comparator | Behavioral: Product Labelling and Sensory modificationsSensory-matched covert calorie reduction, unlabelled |
| Sensory Matched/Labelled | Experimental | Behavioral: Product Labelling and Sensory modificationsSensory-matched explicit calorie reduction, labelled |
| Sensory Reduced/Labelled | Experimental | Behavioral: Product Labelling and Sensory modificationsSensory-reduced explicit calorie reduction, labelled |
| Sensory Enhanced/Labelled | Experimental | Behavioral: Product Labelling and Sensory modificationsSensory-enhanced explicit calorie reduction, labelled |
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
- English Speaking
Key exclusion criteria (6 listed)
- People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
- Individuals who are currently following a diet program
- 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
- Regular smokers (> 5 cigarettes per week)
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 |
|---|---|---|
| Product Labelling and Sensory modificationsthe beverages varied in the label that was attached (no label or a 'Healthier Choice' label) and the sensory matching of the calorie reduction (sensory matched, reduced or enhanced). | Behavioural | Sensory Enhanced/Labelled, Sensory Matched/Labelled, Sensory Matched/Unlabelled, Sensory Reduced/Labelled |
Primary outcome
Ad libitum intake of a later lunch meal (calories - kcal)
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.
3 secondary outcomes
Changes in rated appetite pre- to post beverage and up to 180 minutes post-consumption, all prior to consuming an ad libitum lunch
Time frame: pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes, + 120 mins, + 150 mins + 180 mins
Sensory ratings after the first sip of the test beverage
Time frame: Measured once upon first tasting the test beverage for up to 5 minute
Energy intake (kcal) for across 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 28 Oct 2019.
- Individual participant dataSharing planned: No
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 Product Labelling and Sensory modifications in people with Markedly Reduced Food Intake and Satiety and Food Intake, 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 6 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 28 Oct 2019. 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 a later lunch meal (calories - kcal) (time frame: Measured once for up to 20 minutes). 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 28 Oct 2019.