- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04994925
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
26
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control ready meal
Control supermarket brand ready meal with high energy density
|
Supermarket brand lasagne ready meal
|
|
EXPERIMENTAL: Test ready meal with low energy density
Slimming world test ready meal with low energy density
|
The Slimming World lasagne ready meal
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
February 8, 2019
Primary Completion (ACTUAL)
November 30, 2019
Study Completion (ACTUAL)
December 23, 2019
Study Registration Dates
First Submitted
July 30, 2021
First Submitted That Met QC Criteria
July 30, 2021
First Posted (ACTUAL)
August 6, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 12, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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