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

NCT03547063 | Suspended

• 1 other identifier: 18/0233
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

Obesity, appetite, taste, fMRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• BOLD signal change after lifestyle intervention

  average of 12 weeks

• BOLD signal in response to taste in severe obesity compared to normal weight

  baseline

• BOLD signal change post-SG

  6 months

• Correlation of taste responses and gut hormones

  baseline

• Correlation of taste responses and gut hormones

  approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2BU, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 27453553 BACKGROUND

• 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.

  PMID: 17934448 BACKGROUND

• 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/

  PMID: 28880516 BACKGROUND

• 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.

  PMID: 27200505 BACKGROUND

• 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.

  PMID: 26580235 BACKGROUND

• 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.

  PMID: 27112067 BACKGROUND

• 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.

  PMID: 23867619 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma and saliva

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel L Batterham, PhD FRCP

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 6, 2018
• Study Start: December 18, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

GB (1)