MRI Based Study to Assess Brain-gut Axis in Obesity

NCT05437653 | Unknown DMC

• 1 other identifier: 19047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The mechanism of neural communication between the brain and gut in the regulation of food intake is complex and not fully understood. Magnetic Resonance Imaging (MRI) is a powerful non-invasive imaging tool that allows studying the function of the brain and gut. The aim of this study is to develop MRI methods to combine brain and gut imaging in a single MRI scan session. The developed techniques will then be used to assess the brain-gut axis to a high fat drink compared with iso-caloric/iso-viscous/iso-volumetric carbohydrate drink in people with obesity and healthy weight participants. The findings could provide a possible explanation for why some people are heavier than others.

Conditions

Obesity

Keywords

obesity; brain-gut axis; functional magnetic resonance imaging; gastric emptying; small bowel water content; high fat meal; carbohydrate meal; Blood-oxygen-level-dependent; cerebral blood flow; resting state fMRI

Outcome Measures

Primary Outcomes (5)

• Changes in appetite- and satiety-related brain responses between drinks ( Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS obese)

  Blood oxygen level-dependent (BOLD) responses to high-calorie, low-calorie and non-food images

  From baseline to up to 2 hours after ingesting the drinks

• Changes in Cerebral blood flow between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  Cerebral blood flow differences

  From baseline to up to 2 hours after ingesting the drinks

• Changes resting state brain networks between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  Alterations in functional brain connectivity/networks in brain regions involved in homeostatic and hedonic brain circuits.

  From baseline to up to 2 hours after ingesting the drinks

• Changes in gastric volume between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  Area Under the Curve of post-prandial gastric volumes, measured by MRI

  From baseline to up to 2 hours after ingesting the drinks

• Correlations between gut and brain responses to assess alterations in brain-gut axis between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  Exploratory correlations between brain and gut responses

  From baseline to up to 2 hours after ingesting the drinks

Secondary Outcomes (4)

• Changes in small bowel water content between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  From baseline to up to 2 hours after ingesting the drinks

• Changes in satiety and appetite regulators between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  From baseline to up to 2 hours after ingesting the drinks

• Changes in satiety and appetite score (VAS) between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)

  From baseline to up to 2 hours after ingesting the drinks

• Correlations between blood, brain and gut and satiety date

  From baseline to up to 2 hours after ingesting the drinks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Healthy weight group ( same age and sex)

Other: Nutritional Drink A; Other: Nutritional Drink B

Obese group

ACTIVE COMPARATOR

Obese group

Other: Nutritional Drink A; Other: Nutritional Drink B

Interventions

Nutritional Drink A OTHER

300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier)

Control group; Obese group

Nutritional Drink B OTHER

300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin)

Control group; Obese group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-45, male and female (females will have the study days arranged during the early phase of the menstrual cycle).
• Body mass index (BMI): normal weight participants ≥ 19 and ≤ 25 Kg/m2, and obese participants \> 30 Kg/m2
• Able to give voluntary written informed consent to participate in the study
• Able to understand the requirements of the study
• Apparently healthy: no medical conditions which might affect study measurements (judged by health questionnaire, and blood screening)

You may not qualify if:

• Any reported history of neurological or gastrointestinal disorders
• Any reported history of surgery that could affect gastrointestinal function (e.g. colectomy, small bowel resection)
• Abnormal screening procedures including depression and eat restriction
• Laboratory results that are clinically significant, including diabetes, dyslipidemia, pancreatitis, or untreated hypertension.
• Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury, assessed by standard MRI safety questionnaire.
• Under medication (expect aspirin/paracetamol), antibiotic or prescribed probiotic treatment in the past 12 weeks.
• Following a medically- or self-prescribed diet during the two weeks prior to the pre-study examination and until the end of the study.
• Reported weight loss or gain ≥ 10 % of bodyweight during the six months period before the pre-study examination
• Pregnancy or breastfeeding declared by candidate
• Smoking
• Left-handed assessed by handedness questionnaire. This is to control for brain's lateralisation effects (activation in one side of the brain) that may show variations between left and right handed participants.
• Participation in another clinical or research study within the previous 3 months of the study
• Cannot lie flat or exceeding the scanner bed weight limit of 250 kg.
• Poor understanding of the spoken and/or written English language

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

RECRUITING

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

• Sally Eldeghaidy, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Eldeghaidy, PhD

CONTACT

0115 84 66003; sally.eldeghaidy@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded study, and the study participant and assessor will be unaware of the nature of the drink. Subjects will be invited into 2 MRI scan visits to investigate the brain and gut responses (brain-gut axis) to a high fat drink and a carbohydrate drink. Drinks will be randomised across participants using research randomizer software (https://www.randomizer.org/).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised parallel trial in human volunteers. Control (normal weight) group VS Obese group and High fat drink VS iso-caloric, iso-viscous Carbohydrate drink

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: June 29, 2022
• Study Start: March 28, 2022
• Primary Completion: April 1, 2023
• Study Completion: December 30, 2023
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)