Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-18

Study Completion Date

2022-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sleeve Gastrectomy (SG)

25 participants, male and female, aged 18-50 years, body mass index (BMI) 35-50 kg/m2, due to undergo primary SG

No interventions assigned to this group

Lifestyle Intervention

25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2

No interventions assigned to this group

Normal Weight

25 participants, aged 18-50 years BMI 18.5-24.9 kg/m2, age and gender matched to group with severe obesity

No interventions assigned to this group

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes