search
Back to results

Ready Meal Consumption, Appetite and Food Intake in Females

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control ready meal
Test ready meal
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Oxford Brookes Centre for Nutrition and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control ready meal

Test ready meal with low energy density

Arm Description

Control supermarket brand ready meal with high energy density

Slimming world test ready meal with low energy density

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Energy intake after ad libitum buffet tea
Total energy consumed at the ad libitum tea given 4 hours after the control/test ready meal
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 30, 2021
Last Updated
August 9, 2021
Sponsor
Oxford Brookes University
search

1. Study Identification

Unique Protocol Identification Number
NCT04994925
Brief Title
Ready Meal Consumption, Appetite and Food Intake in Females
Official Title
The Effects of Ready Meal Consumption on Self-reported Appetite Ratings and Subsequent Food Intake in Females
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control ready meal
Arm Type
Active Comparator
Arm Description
Control supermarket brand ready meal with high energy density
Arm Title
Test ready meal with low energy density
Arm Type
Experimental
Arm Description
Slimming world test ready meal with low energy density
Intervention Type
Other
Intervention Name(s)
Control ready meal
Intervention Description
Supermarket brand lasagne ready meal
Intervention Type
Other
Intervention Name(s)
Test ready meal
Intervention Description
The Slimming World lasagne ready meal
Primary Outcome Measure Information:
Title
Visual Analogue Scale measurements for Hunger
Description
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.
Time Frame
9 hours
Title
Visual Analogue Scale measurements for Fullness
Description
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.
Time Frame
9 hours
Title
Visual Analogue Scale measurements for Desire to Eat
Description
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.
Time Frame
9 hours
Title
Visual Analogue Scale measurements for Prospective Food Consumption
Description
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.
Time Frame
9 hours
Title
Energy intake after ad libitum buffet tea
Description
Total energy consumed at the ad libitum tea given 4 hours after the control/test ready meal
Time Frame
4 hours
Title
Macronutrient intake after ad libitum buffet tea
Description
Total macronutrient amounts consumed at the ad libitum tea given 4 hours after the control/test ready meal
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Visual Analogue Scale measurements of thirst
Description
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.
Time Frame
9 hours
Title
Visual Analogue Scale measurements of nausea
Description
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.
Time Frame
9 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Hillier, PhD
Organizational Affiliation
Solent University
Official's Role
Study Director
Facility Information:
Facility Name
Oxford Brookes Centre for Nutrition and Health
City
Oxford
ZIP/Postal Code
OX3 0BP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data is confidential and owned by the Study Sponsor and Collaborator.

Learn more about this trial

Ready Meal Consumption, Appetite and Food Intake in Females

We'll reach out to this number within 24 hrs