NCT04994925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

July 30, 2021

Last Update Submit

August 9, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Visual Analogue Scale measurements of thirst

    9 hours

  • Visual Analogue Scale measurements of nausea

    9 hours

Study Arms (2)

Control ready meal

ACTIVE COMPARATOR

Control supermarket brand ready meal with high energy density

Other: Control ready meal

Test ready meal with low energy density

EXPERIMENTAL

Slimming world test ready meal with low energy density

Other: Test ready meal

Interventions

Supermarket brand lasagne ready meal

Control ready meal

The Slimming World lasagne ready meal

Test ready meal with low energy density

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Brookes Centre for Nutrition and Health

Oxford, OX3 0BP, United Kingdom

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Hillier, PhD

    Solent University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 6, 2021

Study Start

February 8, 2019

Primary Completion

November 30, 2019

Study Completion

December 23, 2019

Last Updated

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

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

Locations