Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Blundell

ORCID ID

Contact details

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

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

http://www.leeds.ac.uk/

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

  1. 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.

  2. 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.

  3. 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.

Editorial Notes