The Reduced Calorie Food and Mood Study

Markedly Reduced Food Intake Clinical Trial

Official title:

The Reduced Calorie Food and Mood Study: Using Sensory Cues to Optimise the Satiety Value of a Reduced-calorie 'Healthier Choice' Product

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138862
• Other study ID #: 2017/01013
• Status: Completed
• Phase: N/A
• Start date: September 9, 2017
• Est. completion date: September 20, 2019

Study information

• Verified date: October 2019
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 20, 2019
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Markedly Reduced Food Intake
• Satiety and Food Intake

Intervention

Behavioral:
• Product Labelling and Sensory modifications
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).

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 once for up to 20 minutes
Secondary	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.	pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes, + 120 mins, + 150 mins + 180 mins
Secondary	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 once upon first tasting the test beverage for up to 5 minute
Secondary	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.	Up to 24 hours