Drivers of eating behaviour during chronic overconsumption

ISRCTN	ISRCTN47291569
DOI	https://doi.org/10.1186/ISRCTN47291569
Protocol serial number	BB/G530141/1
Sponsor	University of Leeds (UK)
Funder	Biotechnology and Biological Sciences Research Council (BBSRC) (UK) - (ref: 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

Primary study design	Interventional
Study design	SIngle centre medium term (12-week) experimental controlled study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Drivers of eating behaviour during chronic overconsumption: role of food hedonics (liking and wanting) and peptide biomarkers on satiation and satiety
Study objectives	The 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) studied	Overweight, obesity
Intervention	Supervised 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 type	Other
Primary outcome measure(s)	Study 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.
Key secondary outcome measure(s)	Study 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.
Completion date	29/10/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	78
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	28/01/2008
Date of final enrolment	29/10/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Psychological Sciences

Leeds
LS2 9JT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes