ObesityTASTERNCT03547063

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

An observational study of Obesity, run by University College, London at 1 site in United Kingdom.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
How many people: 75 participants
Where: 1 siteUnited Kingdom
Study dates: 18 Dec 2018to Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

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.

Who may be able to join

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.

Show all 19Show fewer

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

Who cannot join

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).

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University College London Hospital
London, NW1 2BU

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Obesity
Keywords: Obesity, appetite, taste, fMRI
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03547063
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

BOLD signal change after SG
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.
Measured: approximately 6 weeks

Secondary outcomes (10)

BOLD signal change after lifestyle intervention
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.
Measured: average of 12 weeks
BOLD signal in response to taste in severe obesity compared to normal weight
Brain responses, as BOLD signal, to taste in the fed and fasted state in severe obesity compared to normal weight
Measured: baseline
BOLD signal change post-SG
Whole brain neural response in BOLD signal to taste, in the fed and fasted state, 6 months following SG versus normal weight
Measured: 6 months
Correlation of taste responses and gut hormones
The relationship between the neural correlates of taste and levels of circulating gut hormones in severe obesity compared to normal weight
Measured: baseline
Correlation of taste responses and gut hormones
The relationship between the neural correlates of taste and levels of circulating gut hormones after 10% weight loss by SG compared to lifestyle intervention
Measured: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
Correlation of taste responses and gut hormones
The relationship between the neural correlates of taste and circulating gut hormone levels
Measured: 6 months post-SG compared to baseline
Correlation of taste responses and gut hormones
The relationship between the neural correlates of taste and levels of circulating gut hormones post-SG compared to normal weight
Measured: 6 months
Brain structure
Comparison of brain structure in severe obesity and normal weight
Measured: Baseline
Brain structure 6 months following SG
Comparison of brain structure 6 months following SG to baseline
Measured: 6 months
Brain structure after 10% weight loss
Comparison of brain structure following 10% weight loss induced by SG versus lifestyle intervention
Measured: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 2018Dec 2022

First posted6 Jun 2018
Study start18 Dec 2018
Primary completionDec 2021 (estimated)
Study completionDec 2022 (estimated)

Why it stopped: COVID-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by University College, LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03547063
Sponsor's protocol ID: 18/0233
Acronym: TASTER
Status last verified: Jan 2021
First submitted: 11 May 2018
Last updated: 20 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Makaronidis JM, Neilson S, Cheung WH, Tymoszuk U, Pucci A, Finer N, Doyle J, Hashemi M, Elkalaawy M, Adamo M, Jenkinson A, Batterham RL. Reported appetite, taste and smell changes following Roux-en-Y gastric bypass and sleeve gastrectomy: Effect of gender, type 2 diabetes and relationship to post-operative weight loss. Appetite. 2016 Dec 1;107:93-105. doi: 10.1016/j.appet.2016.07.029. Epub 2016 Jul 22.
PubMed 27453553
Batterham RL, ffytche DH, Rosenthal JM, Zelaya FO, Barker GJ, Withers DJ, Williams SC. PYY modulation of cortical and hypothalamic brain areas predicts feeding behaviour in humans. Nature. 2007 Nov 1;450(7166):106-9. doi: 10.1038/nature06212. Epub 2007 Oct 14.
PubMed 17934448
Neseliler S, Han JE, Dagher A. The Use of Functional Magnetic Resonance Imaging in the Study of Appetite and Obesity. In: Harris RBS, editor. Appetite and Food Intake: Central Control. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2017. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK453146/
PubMed 28880516
Zhang Y, Ji G, Xu M, Cai W, Zhu Q, Qian L, Zhang YE, Yuan K, Liu J, Li Q, Cui G, Wang H, Zhao Q, Wu K, Fan D, Gold MS, Tian J, Tomasi D, Liu Y, Nie Y, Wang GJ. Recovery of brain structural abnormalities in morbidly obese patients after bariatric surgery. Int J Obes (Lond). 2016 Oct;40(10):1558-1565. doi: 10.1038/ijo.2016.98. Epub 2016 May 20.
PubMed 27200505
Goldstone AP, Miras AD, Scholtz S, Jackson S, Neff KJ, Penicaud L, Geoghegan J, Chhina N, Durighel G, Bell JD, Meillon S, le Roux CW. Link Between Increased Satiety Gut Hormones and Reduced Food Reward After Gastric Bypass Surgery for Obesity. J Clin Endocrinol Metab. 2016 Feb;101(2):599-609. doi: 10.1210/jc.2015-2665. Epub 2015 Nov 18.
PubMed 26580235
Faulconbridge LF, Ruparel K, Loughead J, Allison KC, Hesson LA, Fabricatore AN, Rochette A, Ritter S, Hopson RD, Sarwer DB, Williams NN, Geliebter A, Gur RC, Wadden TA. Changes in neural responsivity to highly palatable foods following roux-en-Y gastric bypass, sleeve gastrectomy, or weight stability: An fMRI study. Obesity (Silver Spring). 2016 May;24(5):1054-60. doi: 10.1002/oby.21464.
PubMed 27112067
Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.
PubMed 23867619

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03547063
Acronym / sponsor ID: TASTER / 18/0233
Conditions: Obesity
Keywords: Obesity, appetite, taste, fMRI
Study type: Observational
Recruitment status: SuspendedReason stopped: COVID-19
Enrolment: 75 participants (estimated)
Lead sponsor: University College, LondonUniversity, hospital or other
Study start: 18 Dec 2018 (actual)
Primary completion: Dec 2021 (estimated)
Study completion: Dec 2022 (estimated)
First posted: 6 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
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.

Key inclusion criteria (19 listed)

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.

Key exclusion criteria (13 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

10 secondary outcomes

BOLD signal change after lifestyle intervention
Time frame: average of 12 weeks
BOLD signal in response to taste in severe obesity compared to normal weight
Time frame: baseline
BOLD signal change post-SG
Time frame: 6 months
Correlation of taste responses and gut hormones
Time frame: baseline
Correlation of taste responses and gut hormones
Time frame: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
Correlation of taste responses and gut hormones
Time frame: 6 months post-SG compared to baseline
Correlation of taste responses and gut hormones
Time frame: 6 months
Brain structure
Time frame: Baseline
Brain structure 6 months following SG
Time frame: 6 months
Brain structure after 10% weight loss
Time frame: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Background: PubMed 27453553Makaronidis JM, Neilson S, Cheung WH, Tymoszuk U, Pucci A, Finer N, Doyle J, Hashemi M, Elkalaawy M, Adamo M, Jenkinson A, Batterham RL. Reported appetite, taste and smell changes following Roux-en-Y gastric bypass and sleeve gastrectomy: Effect of gender, type 2 diabetes and relationship to post-operative weight loss. Appetite. 2016 Dec 1;107:93-105. doi: 10.1016/j.appet.2016.07.029. Epub 2016 Jul 22.
Background: PubMed 17934448Batterham RL, ffytche DH, Rosenthal JM, Zelaya FO, Barker GJ, Withers DJ, Williams SC. PYY modulation of cortical and hypothalamic brain areas predicts feeding behaviour in humans. Nature. 2007 Nov 1;450(7166):106-9. doi: 10.1038/nature06212. Epub 2007 Oct 14.
Background: PubMed 28880516Neseliler S, Han JE, Dagher A. The Use of Functional Magnetic Resonance Imaging in the Study of Appetite and Obesity. In: Harris RBS, editor. Appetite and Food Intake: Central Control. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2017. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK453146/
Background: PubMed 27200505Zhang Y, Ji G, Xu M, Cai W, Zhu Q, Qian L, Zhang YE, Yuan K, Liu J, Li Q, Cui G, Wang H, Zhao Q, Wu K, Fan D, Gold MS, Tian J, Tomasi D, Liu Y, Nie Y, Wang GJ. Recovery of brain structural abnormalities in morbidly obese patients after bariatric surgery. Int J Obes (Lond). 2016 Oct;40(10):1558-1565. doi: 10.1038/ijo.2016.98. Epub 2016 May 20.
Background: PubMed 26580235Goldstone AP, Miras AD, Scholtz S, Jackson S, Neff KJ, Penicaud L, Geoghegan J, Chhina N, Durighel G, Bell JD, Meillon S, le Roux CW. Link Between Increased Satiety Gut Hormones and Reduced Food Reward After Gastric Bypass Surgery for Obesity. J Clin Endocrinol Metab. 2016 Feb;101(2):599-609. doi: 10.1210/jc.2015-2665. Epub 2015 Nov 18.
Background: PubMed 27112067Faulconbridge LF, Ruparel K, Loughead J, Allison KC, Hesson LA, Fabricatore AN, Rochette A, Ritter S, Hopson RD, Sarwer DB, Williams NN, Geliebter A, Gur RC, Wadden TA. Changes in neural responsivity to highly palatable foods following roux-en-Y gastric bypass, sleeve gastrectomy, or weight stability: An fMRI study. Obesity (Silver Spring). 2016 May;24(5):1054-60. doi: 10.1002/oby.21464.
Background: PubMed 23867619Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rachel L Batterham, PhD FRCP principal investigator

UCL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BOLD signal change after SG (time frame: approximately 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547063, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.