OverweightNCT04994925
Ready Meal Consumption, Appetite and Food Intake in Females
A study testing Test ready meal in people with Overweight, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Test ready meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Feb 2019to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes Centre for Nutrition and Health
Oxford, OX3 0BP
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Control ready meal, Test ready meal
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ready mealOther
Supermarket brand lasagne ready meal
Test ready mealOther
The Slimming World lasagne ready meal
| Study group | Role | What they receive |
|---|---|---|
| Control ready meal | Active comparator | Control supermarket brand ready meal with high energy density Receives: Other: Control ready meal |
| Test ready meal with low energy density | Experimental | Slimming world test ready meal with low energy density Receives: Other: Test ready meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale measurements for Hunger
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.
Measured: 9 hours
Visual Analogue Scale measurements for Fullness
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.
Measured: 9 hours
Visual Analogue Scale measurements for Desire to Eat
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.
Measured: 9 hours
Visual Analogue Scale measurements for Prospective Food Consumption
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.
Measured: 9 hours
Energy intake after ad libitum buffet tea
Total energy consumed at the ad libitum tea given 4 hours after the control/test ready meal
Measured: 4 hours
Macronutrient intake after ad libitum buffet tea
Total macronutrient amounts consumed at the ad libitum tea given 4 hours after the control/test ready meal
Measured: 4 hours
Secondary outcomes (2)
Visual Analogue Scale measurements of thirst
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.
Measured: 9 hours
Visual Analogue Scale measurements of nausea
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.
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start8 Feb 2019
- Primary completion30 Nov 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sangeetha Thondre, Oxford Brookes University
- Investigators
- Sarah Hillier, PhD, Study director, Solent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994925
- Sponsor's protocol ID
- 0119_44
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is confidential and owned by the Study Sponsor and Collaborator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ready Meal Consumption on Self-reported Appetite Ratings and Subsequent Food Intake in Females
- ClinicalTrials.gov ID
- NCT04994925
- Acronym / sponsor ID
- 0119_44
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control ready meal | Active comparator | Other: Control ready mealControl supermarket brand ready meal with high energy density |
| Test ready meal with low energy density | Experimental | Other: Test ready mealSlimming world test ready meal with low energy density |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- healthy, non-smoking females aged between 18-65 years with a BMI ≥ 25 kg/m2.
Key exclusion criteria (12 listed)
- females aged below 18 and above 65 years
- BMI less than 25 kg/m2.
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control ready mealSupermarket brand lasagne ready meal | Other | Control ready meal |
| Test ready mealThe Slimming World lasagne ready meal | Other | Test ready meal with low energy density |
Primary outcome
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.
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.
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.
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.
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
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
2 secondary outcomes
Visual Analogue Scale measurements of thirst
Time frame: 9 hours
Visual Analogue Scale measurements of nausea
Time frame: 9 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No. The data is confidential and owned by the Study Sponsor and Collaborator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hillier, PhD study director
Solent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test ready meal in people with Overweight, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale measurements for Hunger (time frame: 9 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.