The Reduced Calorie Food and Mood Study

NCT04138862 | Completed

• 1 other identifier: 2017/01013
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Markedly Reduced Food Intake; Satiety and Food Intake

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  Up to 24 hours

Study Arms (4)

Sensory Matched/Unlabelled

ACTIVE COMPARATOR

Sensory-matched covert calorie reduction, unlabelled

Behavioral: Product Labelling and Sensory modifications

Sensory Matched/Labelled

EXPERIMENTAL

Sensory-matched explicit calorie reduction, labelled

Behavioral: Product Labelling and Sensory modifications

Sensory Reduced/Labelled

EXPERIMENTAL

Sensory-reduced explicit calorie reduction, labelled

Behavioral: Product Labelling and Sensory modifications

Sensory Enhanced/Labelled

EXPERIMENTAL

Sensory-enhanced explicit calorie reduction, labelled

Behavioral: Product Labelling and Sensory modifications

Interventions

Product Labelling and Sensory modifications BEHAVIORAL

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).

Sensory Enhanced/Labelled; Sensory Matched/Labelled; Sensory Matched/Unlabelled; Sensory Reduced/Labelled

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 21 and 50 years
• English Speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Interventions

Product Labeling

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture

Study Officials

• Keri McCrickerd, PhD

  Clinical Nutrition Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind (participant unaware of the meal manipulations)
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: Mixed Design: 4 x Beverage Contexts (assessed in parallel to reduce demand awareness) 2 x Energy Density (assessed as full crossover)

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: September 9, 2017
• Primary Completion: September 9, 2018
• Study Completion: September 20, 2019
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)