Clinical trial NCT04138862: The Reduced Calorie Food and Mood 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Markedly Reduced Food Intake
Satiety and Food Intake
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2019-10-25
Enrollment: 121
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Mixed Design:

4 x Beverage Contexts (assessed in parallel to reduce demand awareness) 2 x Energy Density (assessed as full crossover)
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 21 and 50 years
* English Speaking

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ad libitum intake of a later lunch meal (calories - kcal)
timeFrame: Measured once for up to 20 minutes
Secondary outcomes:
measure: Changes in rated appetite pre- to post beverage and up to 180 minutes post-consumption, all prior to consuming an ad libitum lunch
timeFrame: pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes, + 120 mins, + 150 mins + 180 mins
measure: Sensory ratings after the first sip of the test beverage
timeFrame: Measured once upon first tasting the test beverage for up to 5 minute
measure: Energy intake (kcal) for across the test day recorded in a Food diary
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
affiliation: Clinical Nutrition Research Centre
name: Keri McCrickerd, PhD
role: PRINCIPAL_INVESTIGATOR
References: