Studying the effects of psychological and bodily factors on eating habits
| ISRCTN | ISRCTN14809377 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14809377 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 251801 |
| Protocol serial number | IRAS 251801 |
| Sponsor | University of Cambridge |
| Funder | Wellcome Trust |
- Submission date
- 09/04/2021
- Registration date
- 28/05/2021
- Last edited
- 26/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Health-harming over-consumption of food is a major contributor to disease and premature death. Widespread and easy environmental availability of aggressively marketed energy-dense foods has led to marked increases in average body mass and in the numbers of people deemed overweight and obese. But a proportion of people appear to be resistant to the environment causing these changes. The variation in susceptibility to these changes appears to be highly inherited and is mostly expressed in terms of neurobehavioural characteristics. The challenge in understanding the routes to over-consumption, is to characterise how metabolic, psychological and environmental factors combine to shape eating behaviours.
This study will investigate factors contributing to appetite and eating in healthy people and in patients for whom eating patterns may have become disrupted. Ultimately, the aim of this study is to understand over-consumption as well as patterns of consumption that have become disrupted as a consequence of disturbances in body-brain communication. In addition, this study will investigate how individual variations in metabolic, endocrine, cognitive and neural characteristics associate with appetite and health-harming patterns of consumption.
Who can participate?
Adult patients with a BMI of between 18.5 and 25 or with a BMI of 30 or above. Additionally groups of adult patients who are undergoing an operation to remove part or all of the stomach (known as a gastrectomy) and those with specific genetic mutations affecting a part of the brain involved in the regulation of appetite and food intake (known as the hypothalamus) will be invited to participate.
What does the study involve?
In this study, participants will be invited for a two day, overnight study in the Cambridge Clinical Research Centre at Addenbrooke’s hospital. Over the two days, participants will be examined using a complementary set of cognitive, neural and behavioural measures, and the study team will characterise how these are influenced by hunger, obesity, clinical changes to metabolic/bodily signalling and changes of the brain processing of these signals.
What are the possible benefits and risks of participating?
There are no direct benefits of taking part in the study. The cognitive and interoceptive tasks are non-invasive and carry no risks. They may become tiring for participants so breaks will be possible throughout.
Magnetic resonance imaging carries risks due to the presence of a strong magnetic field. We have a standardised list of exclusion features (including the presence of metal in the body, implants, pregnancy) and participants will be carefully evaluated by the radiographer to ensure minimisation of risks. Venepuncture may carry small risks: this will be done in a clinical setting by trained staff.
Where is the study run from?
University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
From January 2017 to December 2022
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Prof Paul Fletcher
pcf22@cam.ac.uk
Contact information
Scientific
Clifford Allbutt Building
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0SZ
United Kingdom
 ORCID ID |
0000-0001-8257-1517 |
|---|---|
| Phone | +44 (0)1223 309128 |
| pcf22@cam.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational case-controlled study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Studying the psychological and interoceptive contributions to eating |
| Study acronym | SPICE |
| Study objectives | 1. Behavioural and neural markers of goal-directed and habitual responding will be altered in obese people compared to lean people, with a shift towards habitual responding in the former. Moreover, the flexible responding to current task demands will be attenuated in those who are less able to resist environmental drives to consumption. 2. The habit-goal balance is fundamentally shaped by current interoceptive state (altered by hunger/satiety) but that this modulation is perturbed in those with altered interoceptive signalling (following upper GI surgery) and with genetic alterations in leptin-melanocortin circuitry 3. The strength of the hormonal response to a fasted/fed manipulation will be associated with the capacity to control stimulus-driven consumption and this effect will be modulated by interoceptive sensitivity |
| Ethics approval(s) | Approved 05/02/2019, East of England - Cambridge Central Research Ethics Committee (Royal Standard Place Nottingham NG1 6FS; +44 (0)2071048384, +44 (0)207 104 8107, +44 (0)207 104 8388; cambridgecentral.rec@hra.nhs.uk), ref: 18/EE/0387 |
| Health condition(s) or problem(s) studied | Obesity, patients with monogenic obesity, and patients undergoing upper GI surgery |
| Intervention | This is an observational study that takes place over two days in the Cambridge Clinical Research Centre at Addenbrooke’s hospital. The study combines a series of cognitive, behavioural neuroimaging, hormonal, and physiological measures in lean and obese people and in patients undergoing gastrectomy or with a mutation in the MC4R, LepR, or SIM1 genes. The measures comprise: 1. Cognitive assessments with a series of learning and decision-making tasks 2. Clinical scales assessing anxiety, depression, stress and eating behaviours 3. Functional and structural brain MRI 4. Metabolic measures (blood glucose, insulin) and gut hormone assays 5. Assessments of physiological indices of stress/arousal (heart rate, heart rate variability, respiration) |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Cognitive measures of habitual and goal-directed learning and their relationships to interoceptive measures of arousal and brain imaging measured using the following measures on the mornings of days 1 and 2: |
| Key secondary outcome measure(s) |
1. General cognitive function measured using task-induced blood oxygenation level signal which serves as a marker for regional brain activity as participants perform simple cognitive tasks over 1 h at approximately 3 pm on days 1 and 2 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 270 |
| Key inclusion criteria | All participants: 1. Aged 18-45 years 2. Written informed consent given 3. Estimated IQ ≥80 measured using the WASI-II Full Scale-2 4. Ambulatory 5. Normal or corrected-to-normal vision Gastrectomy patient group: 1. Aged 18-60 years 2. If post-operative, clinically stable Monogenic obesity patient group: 1. Identified mutation in MC4R, LepR, or SIM1 genes |
| Key exclusion criteria | All participants: 1. Not fluent English speaker 2. Current serious neurological or psychiatric illness, including neurodevelopmental disorders; schizophrenia spectrum and other psychotic disorders; bipolar and related disorders; substance-related and addictive disorders; obsessive-compulsive and related disorders; anorexia nervosa, bulimia nervosa, binge-eating disorder, or otherwise specified feeding or eating disorder; previous bariatric or gastric bypass (Roux-en-Y) surgery 3. Type 1 or Type 2 diabetes 4. Evidence of anaemia, metabolic or cardiovascular disease, or disease that may influence metabolism or blood measurements (such as cancer or thyroid disease) 5. Dietary restrictions that cannot be accommodated by the metabolic kitchen 6. Pregnancy or lactation 7. Contraindications to MRI scanning (such as pacemakers, metallic prostheses such as cochlear implants or heart valves, or shrapnel fragments) 8. Claustrophobic to a degree that they would feel uncomfortable in the MRI scanner Lean group: 1. Left-handedness 2. BMI outside of the range 18.5-24.9 kg/m² 3. Lifetime history of any of the following DSM-5 psychiatric conditions: 3.1. Obsessive-Compulsive and Related Disorders 3.2. Trauma- and Stressor-Related Disorders 3.3. Dissociative Disorders 3.4. Somatic Symptom and Related Disorders 3.5. Disruptive, Impulse-Control, and Conduct Disorders 4. Recent history (previous 6 months) of any of the following DSM-5 psychiatric conditions 4.1. Depressive Disorders 4.2. Anxiety Disorders 5. Current use of antidepressant or anxiolytic medication Diet-induced obesity group: 1. Left-handedness 2. BMI <29.9 kg/m² 3. Lifetime history of any of the following DSM-5 psychiatric conditions: 3.1. Obsessive-Compulsive and Related Disorders 3.2. Trauma- and Stressor-Related Disorders 3.3. Dissociative Disorders 3.4. Somatic Symptom and Related Disorders 3.5. Disruptive, Impulse-Control, and Conduct Disorders 4. Recent history (previous 6 months) of any of the following DSM-5 psychiatric conditions 4.1. Depressive Disorders 4.2. Anxiety Disorders 5. Current use of antidepressant or anxiolytic medication Gastrectomy and monogenic obesity patient groups: 1. Treating clinician has any concerns that participation in the study may have a deleterious effect on the participant’s health or ongoing treatment |
| Date of first enrolment | 01/02/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hills Road
Cambridge
CB2 0SZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/04/2021: Trial’s existence confirmed by East of England - Cambridge Central Research Ethics Committee.
