Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547063
Recruitment Status : Suspended (COVID-19)
First Posted : June 6, 2018
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
University College, London

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).

Condition or disease
Obesity

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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
Lifestyle Intervention
25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2
Normal Weight
25 participants, aged 18-50 years BMI 18.5-24.9 kg/m2, age and gender matched to group with severe obesity



Primary Outcome Measures :
  1. BOLD signal change after SG [ Time Frame: approximately 6 weeks ]
    To determine the effect of SG, at 10% weight loss, upon whole-brain neural response to taste, in the fed and fasted state, detected through blood-oxygen-level dependent (BOLD) signal, in patients with severe obesity.


Secondary Outcome Measures :
  1. BOLD signal change after lifestyle intervention [ Time Frame: average of 12 weeks ]
    The effect of 10% weight loss in patients with severe obesity induced by a lifestyle intervention on BOLD signal to taste in the fed and fasted state and compared to SG.

  2. BOLD signal in response to taste in severe obesity compared to normal weight [ Time Frame: baseline ]
    Brain responses, as BOLD signal, to taste in the fed and fasted state in severe obesity compared to normal weight

  3. BOLD signal change post-SG [ Time Frame: 6 months ]
    Whole brain neural response in BOLD signal to taste, in the fed and fasted state, 6 months following SG versus normal weight

  4. Correlation of taste responses and gut hormones [ Time Frame: baseline ]
    The relationship between the neural correlates of taste and levels of circulating gut hormones in severe obesity compared to normal weight

  5. Correlation of taste responses and gut hormones [ Time Frame: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group ]
    The relationship between the neural correlates of taste and levels of circulating gut hormones after 10% weight loss by SG compared to lifestyle intervention

  6. Correlation of taste responses and gut hormones [ Time Frame: 6 months post-SG compared to baseline ]
    The relationship between the neural correlates of taste and circulating gut hormone levels

  7. Correlation of taste responses and gut hormones [ Time Frame: 6 months ]
    The relationship between the neural correlates of taste and levels of circulating gut hormones post-SG compared to normal weight

  8. Brain structure [ Time Frame: Baseline ]
    Comparison of brain structure in severe obesity and normal weight

  9. Brain structure 6 months following SG [ Time Frame: 6 months ]
    Comparison of brain structure 6 months following SG to baseline

  10. Brain structure after 10% weight loss [ Time Frame: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group ]
    Comparison of brain structure following 10% weight loss induced by SG versus lifestyle intervention


Biospecimen Retention:   Samples With DNA
Blood, plasma and saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547063


Locations
Layout table for location information
United Kingdom
University College London Hospital
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
University College, London
Investigators
Layout table for investigator information
Principal Investigator: Rachel L Batterham, PhD FRCP UCL
Publications:

Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03547063    
Other Study ID Numbers: 18/0233
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Obesity, appetite, taste, fMRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight