The Impact of Food Reformulation on Energy Intake

Obesity Clinical Trial

Official title:

The Impact of Food Reformulation on Energy Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05744050
• Other study ID #: Reformulation study
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2024
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. A number of studies suggest that when energy density of a food is manipulated it has a linear effect on energy intake, because consumers tend to eat a constant weight of food. However, recent observational research suggested that up to approximately 1.5-2kcal/g, individuals are relatively insensitive to changes in energy density, and there is no indication of compensation through altering meal size. However, upwards of approximately 1.5-2kcal/g, the authors proposed that individuals compensate for increases in energy density by selecting and consuming smaller meal sizes. The investigators aim to measure participant's consumption (in grams and kilocalories) of three meals at low, medium and high energy densities, and to measure later food intake to observe any evidence of later compensation in response to experimental condition

Description:

See attached protocol document.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently reside in the United Kingdom
• Over the age of 18 years
• Fluent English speaker
• Like the test foods
• Have a BMI between the ranges of 18.5 and 35.

Exclusion Criteria:

• Pregnant/breastfeeding
• Partaking in a fast or other restrictive eating for religious reasons at time of participation
• Currently following a diet
• On medication that affects appetite
• Being a smoker
• Current or historic eating disorder
• Dietary restrictions/intolerances including:
• Any allergies
• Vegan/vegetarian
• Gluten-free
• Dairy-free
• Sugar-free

Related Conditions & MeSH terms

• Diet, Healthy
• Eating Behavior
• Obesity

Intervention

Behavioral:
• Low energy density lunch
Particpants will be provided with a lunch low in energy density (~1.1kcal/g)
• Medium energy density lunch
Participants will be provided with a lunch medium in energy density(~1.7kcal/g)
• High energy density lunch
Participants will be provided with a lunch high in energy density (~3kcal/g)

Locations

Country	Name	City	State
United Kingdom	University of Liverpool	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute intake	The investigators will observe differences in consumption (g/kcal) when participants are given a meal covertly manipulated to be low, medium or high in energy density.	30 minutes after intervention administered
Secondary	Later intake	The investigators will measure later food intake, in order to observe any evidence of later compensation in response to experimental condition.	Up to 7 hours after intervention administered