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

Obesity Clinical Trial

— TASTER  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03547063
• Other study ID #: 18/0233
• Status: Suspended
• Start date: December 18, 2018
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 resonance imaging (fMRI).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 75
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. Epub 2007 Oct 14. — View Citation

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. — View Citation

Goldstone AP, Miras AD, Scholtz S, Jackson S, Neff KJ, Pénicaud 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. — View Citation

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, Rüther UU, Brüning 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 6 weeks
Secondary	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.	average of 12 weeks
Secondary	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	baseline
Secondary	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	6 months
Secondary	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	baseline
Secondary	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	approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
Secondary	Correlation of taste responses and gut hormones	The relationship between the neural correlates of taste and circulating gut hormone levels	6 months post-SG compared to baseline
Secondary	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	6 months
Secondary	Brain structure	Comparison of brain structure in severe obesity and normal weight	Baseline
Secondary	Brain structure 6 months following SG	Comparison of brain structure 6 months following SG to baseline	6 months
Secondary	Brain structure after 10% weight loss	Comparison of brain structure following 10% weight loss induced by SG versus lifestyle intervention	approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group