Drivers of eating behaviour during chronic overconsumption

ISRCTN ISRCTN47291569
DOI https://doi.org/10.1186/ISRCTN47291569
Secondary identifying numbers BB/G530141/1
Submission date
14/09/2010
Registration date
27/01/2011
Last edited
15/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Blundell
Scientific

Institute of Psychological Sciences
University of Leeds
Leeds
LS2 9JT
United Kingdom

Study information

Study designSIngle centre medium term (12-week) experimental controlled study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleDrivers of eating behaviour during chronic overconsumption: role of food hedonics (liking and wanting) and peptide biomarkers on satiation and satiety
Study objectivesThe aim of this study follows on from the findings of our previous BBSRC grant (BBS/B/05079: “The impact of physical activity on appetite control”). Participants are involved in two concurrent sub-studies. Study 1, looks at changes at energy balance over the duration of the intervention. Study 2 looks at the kinetics of gut peptides after consumption of breakfast. During the exercise intervention in study 1, a proportion of participants are expected to show compensatory increases in energy intake which will offset the energy deficit. This ‘relative overconsumption’ is safe because it does not result in significant weight gain, but does confer other health benefits such as increased fitness, lowered blood pressure, resting heart rate and reduced waist circumference (a marker of visceral fat).

The principal objective of the study is to characterise and compare those participants who lose the amount of weight predicted by their exercise expenditure (based on measured changes in their fat and lean mass) with those participants who do not lose the amount of weight predicted.

The outcomes of the study will yield important information about the processes that underpin eating behaviour during a prolonged elevation in food intake (relative overconsumption) in response to an increase in energy expenditure from exercise.
Ethics approval(s)UK National Health Service Research Ethics Committee Leeds (West) approved on the 20th January 2009 (ref: 09/H1307/7)
Health condition(s) or problem(s) studiedOverweight, obesity
InterventionSupervised exercise to expend 500 kcal 5 times/week for 12 weeks. Assessments at week 0, week 6 and week 12. No exercise overweight/obese and lean comparators.
Intervention typeOther
Primary outcome measureStudy 1:
Change in energy balance from week 0 to week 12 measured by the product of the energy cost of a unit change in fat mass by the observed change in fat mass and summing it with the product of the energy cost of a unit change in lean mass by the observed change in lean mass.

Study 2:
Rise and fall in concentration of gut peptides assayed from the participants’ blood samples in the four hour period following consumption of breakfast.
Secondary outcome measuresStudy 1:
1.1. Cardiovascular fitness at week 12 will be measured by VO2 maximal test of aerobic capacity
1.2. Resting heart rate and Blood pressure at week 12 will be measured by an integrated digital blood pressure and heart rate monitor with inflatable cuff
1.3. Resting metabolic rate at week 12 will be measured by Gas Exchange Measurement
1.4. Substrate oxidation at week 12 will be measured by indirect calorimetry
1.5. Eating behaviour at week 12 will be measured by intake of test meals designed to vary in macronutrient composition (20:65:15 and 35:50:15, % carbohydrate:fat:protein) and quantitative ratings of hunger and satiety by questionnaire

Study 2:
Quantitative ratings of hunger and satiety by questionnaire.
Overall study start date28/01/2008
Completion date29/10/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants78
Key inclusion criteria1. 18 - 55 years old
2. Sedentary lifestyle (no leisure-time physical activity in previous 6 months)
3. Body Mass Index (BMI) between 27 - 38 kg/m2 or 18 - 23 kg/m2 (lean control)
4. Signed consent given
5. No objection from participant's GP
Key exclusion criteria1. Inability to fully comply with intervention or study procedures
2. Insufficient English language skills to complete all questionnaires
3. Pre-existing injuries or conditions that could be aggravated by regular physical activity
4. Medication that could influence accumulation or expenditure of energy
5. Cardiac problems (arrhythmia, Congestive heart disease)
6. Uncontrolled hypertension
7. Genetic syndromes associated with obesity
8. Presence of untreated hypothyroidism
9. Recent body weight change (± 2 kg in previous 3 months)
10. Currently following weight loss regime
11. Food allergies or aversions
Date of first enrolment28/01/2008
Date of final enrolment29/10/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Psychological Sciences
Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

c/o Rachel De Souza
Leeds
LS2 9JT
England
United Kingdom

Website http://www.leeds.ac.uk/
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Research council

Biotechnology and Biological Sciences Research Council (BBSRC) (UK) - (ref: BB/G530141/1)
Government organisation / National government
Alternative name(s)
UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/06/2011 Yes No
Results article results 01/02/2012 Yes No
Results article results 01/01/2013 Yes No