The Reduced Calorie Food and Mood Study

NCT ID: NCT04138862

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-09

Study Completion Date

2019-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Markedly Reduced Food Intake Satiety and Food Intake

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Mixed Design:

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

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Single Blind (participant unaware of the meal manipulations)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sensory Matched/Unlabelled

Sensory-matched covert calorie reduction, unlabelled

Group Type ACTIVE_COMPARATOR

Product Labelling and Sensory modifications

Intervention Type 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 Matched/Labelled

Sensory-matched explicit calorie reduction, labelled

Group Type EXPERIMENTAL

Product Labelling and Sensory modifications

Intervention Type 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 Reduced/Labelled

Sensory-reduced explicit calorie reduction, labelled

Group Type EXPERIMENTAL

Product Labelling and Sensory modifications

Intervention Type 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-enhanced explicit calorie reduction, labelled

Group Type EXPERIMENTAL

Product Labelling and Sensory modifications

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Keri McCrickerd

Senior Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Keri McCrickerd, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Research Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Nutrition Research Centre

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017/01013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Umami Exposure on MSG Induced-satiation
NCT06725615 NOT_YET_RECRUITING NA