Clinical trial NCT03547063: Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour
Official title: Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour: An fMRI Study Evaluating Brain Structure, Connectivity and Responses to Taste Across Different Body Weight Categories and in Response to Weight Loss
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Obesity
Keywords: Obesity, appetite, taste, fMRI
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant groups:

1. Participants with severe obesity

   1. SG: 25 participants, male and female, aged 18-50 years, body mass index (BMI) 35-50 kg/m2, due to undergo primary SG.
   2. Lifestyle intervention: 25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2.
2. Participants with normal weight: 25 participants, aged 18-50 years BMI 18.5-24.9 kg/m2, age and gender matched to group with severe obesity.

Brief summary: The aim of this study is to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals, using functional magnetic resonance imaging (fMRI).

Detailed description: This is an observational study aiming to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals using functional magnetic resonance imaging (fMRI). Drops of liquid foods and a control solution will be delivered to the participants' mouth during fMRI scanning. Body weight, gut hormones from serial blood samples, appetite scores and taste will be assessed at each study visit.

Eligibility criteria: Inclusion Criteria:

* Female and male adults aged 18-50 years.
* Right-handed.
* No MRI contra-indications.
* Weight stable at time of recruitment, defined as less than 5% variation in body weight over the preceding 3 months.
* Proficient in written and spoken English.
* Able to comply with study protocol.
* Willing and able to provide written informed consent.
* Participants must be registered with a general practitioner (GP).
* Willing for their treating consultant or their GP and the study team to be informed in the event of an incidental abnormal finding being detected by the investigations or assessments that form part of this study.
* Able to lie flat for 1 hour.

Group-specific inclusion criteria:

* SG group:

  * BMI of 35-50 kg/m2
  * Planned to undergo primary SG surgery and fulfilling eligibility criteria for bariatric surgery.
* Lifestyle intervention group:

  * BMI of 35-50 kg/m2
  * Willing to undergo a lifestyle intervention programme with a view to achieving approximately 10% weight loss.
* Normal weight group:

  * BMI 18.5-24.9 kg/m2

Exclusion Criteria:

* Body weight greater than 130kg (due to weight limit of MRI Scanner).
* Contraindications specific to MRI scanning: metallic implants (cardiac pacemakers, aneurysm clips, permanent eye lining, cochlear implants or anyone who has been exposed to metallic flakes or splinters).
* Type 1 and type 2 diabetes (in view of altered circulated gut hormone profiles and gustatory function).
* Menopause (in view of findings that the menopause affects gustatory function).
* Smoking (in view of the fact that smoking affects salivary gut hormones and gustatory function).
* Vitamin B12 or zinc deficiency (in view of deficiencies affecting gustatory function).
* Untreated severe depression.
* Eating disorders including bulimia and self-induced vomiting.
* Neurological or psychiatric conditions.
* Acute illness or chronic conditions that may impact upon gustatory and olfactory function.
* Acute illness or chronic conditions that may impact upon post-operative weight loss.
* Known or suspected history of HIV, Hepatitis B or C or other blood-borne diseases (in view of safety regulations regarding exposure to blood products)
* Pregnancy or lactation.

Primary outcomes:
measure: BOLD signal change after SG
timeFrame: approximately 6 weeks
Secondary outcomes:
measure: BOLD signal change after lifestyle intervention
timeFrame: average of 12 weeks
measure: BOLD signal in response to taste in severe obesity compared to normal weight
timeFrame: baseline
measure: BOLD signal change post-SG
timeFrame: 6 months
measure: Correlation of taste responses and gut hormones
timeFrame: baseline
measure: Correlation of taste responses and gut hormones
timeFrame: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
measure: Correlation of taste responses and gut hormones
timeFrame: 6 months post-SG compared to baseline
measure: Correlation of taste responses and gut hormones
timeFrame: 6 months
measure: Brain structure
timeFrame: Baseline
measure: Brain structure 6 months following SG
timeFrame: 6 months
measure: Brain structure after 10% weight loss
timeFrame: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: UCL
name: Rachel L Batterham, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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