Ready Meal Consumption, Appetite and Food Intake in Females

August 9, 2021 updated by: Dr. Sangeetha Thondre, Oxford Brookes University

The Effects of Ready Meal Consumption on Self-reported Appetite Ratings and Subsequent Food Intake in Females

Overweight and obesity are public health concerns and there is a forecast rise in the consumption of ready meals that are generally high in saturated fat and low in fibre. Slimming World, a commercial weight management organisation has designed a range of ready meals in line with their weight management programme, which advocates an unrestricted intake of low energy dense food in order to aid in weight loss. Hence, it is valuable to understand the satiating properties of ready meals in order to establish if specific ready meals can enhance satiety and contribute to reducing subsequent energy intake. This study aims to explore the effect of ready meals on short-term satiety and food intake among females with a BMI ≥ 25 kg/m2.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 26 female participants aged between 18-65 years attended Oxford Brookes Centre for Nutrition and Health for two separate testing days. The study aimed to investigate the effects of energy matched ready meals (calorie-matched but differing quantities of protein and fat) on appetite and subsequent energy and macronutrient intake. The ready meals (Control = supermarket brand and Test = Slimming World) differed in energy density and macronutrient composition, with satiety responses investigated in the studies. The participants consumed a standard breakfast and four hours later consumed either a test ready meal (lasagne, higher energy density) or the control ready meal (lower energy density). Four hours after lunch participants food intake was measured during an ad libitum buffet tea. Additionally, satiety measurements were recorded using visual analogue scales throughout and participants completed a weighed food diary for the remainder of the test day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 0BP
        • Oxford Brookes Centre for Nutrition and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • healthy, non-smoking females aged between 18-65 years with a BMI ≥ 25 kg/m2.

    • had no known food allergies to the study foods,
    • had no eating disorders,
    • were not following a special diet (e.g. vegetarian, halal),
    • were not taking any medication or supplements known to affect appetite or weight within the month prior to and/or during the study,
    • were not pregnant, planning to become pregnant or breastfeeding,
    • had not significantly changed their physical activity in the 2-4 weeks prior to the study or who did not intend on changing them during the study,
    • were not receiving systemic or local treatment likely to interfere with the evaluation of the study parameters,

Exclusion Criteria:

  • females aged below 18 and above 65 years
  • BMI less than 25 kg/m2.

  • smokers

    • had food allergies to the study foods,
    • had eating disorders,
    • were following a special diet (e.g. vegetarian, halal),
    • were taking any medication or supplements known to affect appetite or weight within the month prior to and/or during the study,
    • were pregnant, planning to become pregnant or breastfeeding,
    • had significantly changed their physical activity in the 2-4 weeks prior to the study or who did not intend on changing them during the study,
    • were receiving systemic or local treatment likely to interfere with the evaluation of the study parameters,
    • had a gastric band/had undergone gastric bypass treatment
    • and/or females who worked in appetite or feeding related areas.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Control ready meal
Control supermarket brand ready meal with high energy density
Other: Control ready meal
Supermarket brand lasagne ready meal
EXPERIMENTAL: Test ready meal with low energy density
Slimming world test ready meal with low energy density
Other: Test ready meal
The Slimming World lasagne ready meal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale measurements for Hunger
Time Frame: 9 hours
Ratings were established prior to breakfast (fasted), then every 30 minutes from commencing breakfast (8 am) until lunch (12 pm). Visual Analogue Scale ratings continued every 15 minutes from commencing lunch until the buffet tea (4 pm), with the last rating being made after finishing the buffet tea. Minimum value 0 mm; maximum value 100 mm; A higher score means worse outcome.
9 hours
Visual Analogue Scale measurements for Fullness
Time Frame: 9 hours
Ratings were established prior to breakfast (fasted), then every 30 minutes from commencing breakfast (8 am) until lunch (12 pm). Visual Analogue Scale ratings continued every 15 minutes from commencing lunch until the buffet tea (4 pm), with the last rating being made after finishing the buffet tea. Minimum value 0 mm; maximum value 100 mm; A higher score means better outcome.
9 hours
Visual Analogue Scale measurements for Desire to Eat
Time Frame: 9 hours
Ratings were established prior to breakfast (fasted), then every 30 minutes from commencing breakfast (8 am) until lunch (12 pm). Visual Analogue Scale ratings continued every 15 minutes from commencing lunch until the buffet tea (4 pm), with the last rating being made after finishing the buffet tea. Minimum value 0 mm; maximum value 100 mm; A higher score means worse outcome.
9 hours
Visual Analogue Scale measurements for Prospective Food Consumption
Time Frame: 9 hours
Ratings were established prior to breakfast (fasted), then every 30 minutes from commencing breakfast (8 am) until lunch (12 pm). Visual Analogue Scale ratings continued every 15 minutes from commencing lunch until the buffet tea (4 pm), with the last rating being made after finishing the buffet tea. Minimum value 0 mm; maximum value 100 mm; A higher score means worse outcome.
9 hours
Energy intake after ad libitum buffet tea
Time Frame: 4 hours
Total energy consumed at the ad libitum tea given 4 hours after the control/test ready meal
4 hours
Macronutrient intake after ad libitum buffet tea
Time Frame: 4 hours
Total macronutrient amounts consumed at the ad libitum tea given 4 hours after the control/test ready meal
4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale measurements of thirst
Time Frame: 9 hours
Ratings were established prior to breakfast (fasted), then every 30 minutes from commencing breakfast (8 am) until lunch (12 pm). Visual Analogue Scale ratings continued every 15 minutes from commencing lunch until the buffet tea (4 pm), with the last rating being made after finishing the buffet tea. Minimum value 0 mm; maximum value 100 mm; A higher score means worse outcome.
9 hours
Visual Analogue Scale measurements of nausea
Time Frame: 9 hours
Ratings were established prior to breakfast (fasted), then every 30 minutes from commencing breakfast (8 am) until lunch (12 pm). Visual Analogue Scale ratings continued every 15 minutes from commencing lunch until the buffet tea (4 pm), with the last rating being made after finishing the buffet tea. Minimum value 0 mm; maximum value 100 mm; A higher score means worse outcome.
9 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford Brookes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sarah Hillier, PhD, Solent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0119_44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is confidential and owned by the Study Sponsor and Collaborator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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