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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04994925
Other study ID # 0119_44
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2019
Est. completion date December 23, 2019

Study information

Verified date August 2021
Source Oxford Brookes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 23, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Control ready meal
Supermarket brand lasagne ready meal
Test ready meal
The Slimming World lasagne ready meal

Locations

Country Name City State
United Kingdom Oxford Brookes Centre for Nutrition and Health Oxford

Sponsors (1)

Lead Sponsor Collaborator
Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 9 hours
Primary 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. 9 hours
Primary 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. 9 hours
Primary 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. 9 hours
Primary Energy intake after ad libitum buffet tea Total energy consumed at the ad libitum tea given 4 hours after the control/test ready meal 4 hours
Primary 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 4 hours
Secondary 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. 9 hours
Secondary 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. 9 hours
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