Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BB/G530141/1
Study information
Scientific title
Drivers of eating behaviour during chronic overconsumption: role of food hedonics (liking and wanting) and peptide biomarkers on satiation and satiety
Acronym
Study hypothesis
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
UK National Health Service Research Ethics Committee Leeds (West) approved on the 20th January 2009 (ref: 09/H1307/7)
Study design
SIngle centre medium term (12-week) experimental controlled study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
28/01/2008
Overall trial end date
29/10/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
78
Participant 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
Recruitment start date
28/01/2008
Recruitment end date
29/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Psychological Sciences
Leeds
LS2 9JT
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
c/o Rachel De Souza
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Biotechnology and Biological Sciences Research Council (BBSRC) (UK) - (ref: BB/G530141/1)
Alternative name(s)
BBSRC
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21651803
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21733267
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23193010
Publication citations
-
Results
Gibbons C, Caudwell P, Finlayson G, King N, Blundell J, Validation of a new hand-held electronic data capture method for continuous monitoring of subjective appetite sensations., Int J Behav Nutr Phys Act, 2011, 8, 57, doi: 10.1186/1479-5868-8-57.
-
Results
Blundell JE, Caudwell P, Gibbons C, Hopkins M, Näslund E, King NA, Finlayson G, Body composition and appetite: fat-free mass (but not fat mass or BMI) is positively associated with self-determined meal size and daily energy intake in humans., Br. J. Nutr., 2012, 107, 3, 445-449, doi: 10.1017/S0007114511003138.
-
Results
Caudwell P, Finlayson G, Gibbons C, Hopkins M, King N, Näslund E, Blundell JE, Resting metabolic rate is associated with hunger, self-determined meal size, and daily energy intake and may represent a marker for appetite., Am. J. Clin. Nutr., 2013, 97, 1, 7-14, doi: 10.3945/ajcn.111.029975.