NCT02012426

Brief Summary

The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.

  • We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
  • We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
  • We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
  • We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

December 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

December 10, 2013

Last Update Submit

May 31, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • Test Meal Energy Intake

    Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.

    Week 0 and week 12

  • 24h Energy Intake

    Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control

    Week 0 and week 12

  • Appetite sensations

    Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control

    Week 0 and week 14

  • Food preference

    Measured changes in food preference and liking and wanting profiles for food (HF\<LF) following consumption of formulated test meal in comparison to equi-energetic control

    Week 0 and week 14

Secondary Outcomes (1)

  • Body Weight

    Weekly from week 0 to week 12

Other Outcomes (3)

  • Food diary

    Week 0 and week 12

  • Accelerometer

    Week 0 and week 12

  • Interview

    Week 12

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants enrolled in commercial weight management program

Behavioral: Weight management program

Control group

ACTIVE COMPARATOR

Participants enrolled in standard care weight management provision

Behavioral: Weight management program

Interventions

Control groupIntervention Group

Eligibility Criteria

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

You may qualify if:

  • BMI of 28 - 45 kg/m2
  • Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
  • Not increased physical activity levels in the past 2-4 weeks
  • Able to eat most everyday foods and fruits and vegetables
  • Written informed consent to be given

You may not qualify if:

  • Significant health problems that could cause confounding effects between intervention and control.
  • Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
  • Pregnant, planning to become pregnant or breastfeeding
  • History of anaphylaxis to food
  • Known food allergies or food intolerance
  • Smokers and those who have recently ceased smoking
  • Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
  • Those who have previously taken part in a commercial weight loss program in the last 6 months? .
  • Participants who work in appetite or feeding related areas
  • Participants unable to consume foods used in the study
  • Participants who have had bariatric surgery
  • Participants with a history of eating disorder
  • Presence of untreated hypothyroidism
  • Inability to fully comply with intervention or study procedures
  • Insufficient English language skills to complete study questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (2)

  • Buckland NJ, Camidge D, Croden F, Myers A, Lavin JH, Stubbs RJ, Blundell JE, Finlayson G. Women with a low-satiety phenotype show impaired appetite control and greater resistance to weight loss. Br J Nutr. 2019 Oct 28;122(8):951-959. doi: 10.1017/S000711451900179X.

  • Buckland NJ, Camidge D, Croden F, Lavin JH, Stubbs RJ, Hetherington MM, Blundell JE, Finlayson G. A Low Energy-Dense Diet in the Context of a Weight-Management Program Affects Appetite Control in Overweight and Obese Women. J Nutr. 2018 May 1;148(5):798-806. doi: 10.1093/jn/nxy041.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Graham S Finlayson, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 16, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations