Effect of Oral Feeding on Gastric Emptying, Gut Blood Flow, and Hormone Responses in Obese and Healthy Weight Subjects
The Effect of Oral Feeding on Gastric Emptying, Small Bowel Water Content, Superior Mesenteric Artery Blood Flow, Plasma Hormone Concentrations and Blood Volume in Obese and Healthy Weight Subjects.
1 other identifier
observational
20
1 country
1
Brief Summary
Obesity is a complicated condition that is poorly understood. The aim of this study is to increase our knowledge of how the condition may arise, and what makes obese people remain obese. We will be investigating 12 people who are overweight and comparing them to 12 people who are lean, to look at how quickly food empties out of the stomach (gastric emptying) and travels through the gut, what the blood flow to the gut is, and also to examine the hormones which are involved in determining how full people feel after eating. In order to do this, we will be using a magnetic resonance imaging (MRI) scanner, and performing blood tests. The rate of gastric emptying may have an impact on satiety (how full one feels) and has been implied in the development of obesity. This effect has been shown to impact on subsequent meal intake to a greater degree in overweight subjects, and may be due to a difference in gastric emptying of food in overweight individuals, or to hormones such as ghrelin, glucagon-like peptide 1, and Peptide YY.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2018
CompletedFirst Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2022
CompletedDecember 4, 2025
November 1, 2025
3.2 years
February 25, 2019
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastric emptying rate
time taken for a standard meal to empty from the stomach, assessed by serial volume measurements of the stomach using magnetic resonance imaging
240 minutes after feeding
Secondary Outcomes (23)
Stomach volume in the fasted state
baseline
Superior mesenteric artery (SMA) blood flow in the fasted state
baseline
superior mesenteric artery (SMA) blood flow response to feeding
240 minutes after feeding
Fasting blood glucose concentration
before feeding
Blood glucose response to feeding
300 minutes after feeding
- +18 more secondary outcomes
Study Arms (2)
Overweight
Otherwise healthy overweight and obese men (BMI 30-40kg/m2) aged 18 to 60 years Group will consume a standard meal (Feeding) and measurements will be made before (baseline) and for 300 minutes after eating
Normal Weight
Healthy normal weight men (BMI 18-25kg/m2, but including those with BMI up to 28kg/m2 if waist circumference \<96cm) aged 18 to 60 years Group will consume a standard meal (Feeding) and measurements will be made before (baseline) and for 300 minutes after eating
Eligibility Criteria
Recruitment will be from the male population residing within 20 miles of the research site. This will include those from Nottinghamshire, Leicestershire and Derbyshire, UK
You may qualify if:
- BMI 30-40 kg/m2
- BMI 18-25 kg/m2; those with BMI up to 28kg/m2 will be included if waist circumference is \<96cm.
- Males
- Aged 18-60yrs
You may not qualify if:
- Acute illness in the preceding 6 weeks
- Taking regular medication
- History of deep vein thrombosis or clotting disorders
- Hypertension
- Diabetes
- Any clinically significant findings at screening
- History of substance abuse
- Demonstrating factors precluding safe MRI
- History of gastrointestinal motility disorders (e.g. gastroesophageal reflux disease -irritable bowel syndrome, gastroparesis, sphincter of Oddi dysfunction, etc.)
- Previous thoracic or abdominal surgery.
- Those who report having ≤3 bowel movements/week or \>2/day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queens Medical Centre
Nottingham, Notts, NG72UH, United Kingdom
Related Publications (6)
Fu XY, Li Z, Zhang N, Yu HT, Wang SR, Liu JR. Effects of gastrointestinal motility on obesity. Nutr Metab (Lond). 2014 Jan 7;11(1):3. doi: 10.1186/1743-7075-11-3.
PMID: 24398016BACKGROUNDVatner SF, Franklin D, Van Citters RL. Mesenteric vasoactivity associated with eating and digestion in the conscious dog. Am J Physiol. 1970 Jul;219(1):170-4. doi: 10.1152/ajplegacy.1970.219.1.170. No abstract available.
PMID: 4393203BACKGROUNDAlyami J, Spiller RC, Marciani L. Magnetic resonance imaging to evaluate gastrointestinal function. Neurogastroenterol Motil. 2015 Dec;27(12):1687-92. doi: 10.1111/nmo.12726.
PMID: 26598049BACKGROUNDHoad CL, Parker H, Hudders N, Costigan C, Cox EF, Perkins AC, Blackshaw PE, Marciani L, Spiller RC, Fox MR, Gowland PA. Measurement of gastric meal and secretion volumes using magnetic resonance imaging. Phys Med Biol. 2015 Feb 7;60(3):1367-83. doi: 10.1088/0031-9155/60/3/1367. Epub 2015 Jan 16.
PMID: 25592405BACKGROUNDTotman JJ, Marciani L, Foley S, Campbell E, Hoad CL, Macdonald IA, Spiller RC, Gowland PA. Characterization of the time course of the superior mesenteric, abdominal aorta, internal carotid and vertebral arteries blood flow response to the oral glucose challenge test using magnetic resonance imaging. Physiol Meas. 2009 Oct;30(10):1117-36. doi: 10.1088/0967-3334/30/10/011. Epub 2009 Sep 16.
PMID: 19759401BACKGROUNDSimpson EJ, Althubeati S, Cordon S, Hoad C, Bush D, Eldeghaidy S, Gowland PA, Macdonald IA, Lobo DN. The effect of oral feeding on gastrointestinal function, motility and appetite-regulating hormones, insulin, glucose and satiety in normal weight individuals and those with obesity. Clin Nutr. 2025 Sep;52:62-71. doi: 10.1016/j.clnu.2025.07.008. Epub 2025 Jul 8.
PMID: 40714600RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dileep Lobo, MD, PhD
University of Nottingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Fellow
Study Record Dates
First Submitted
February 25, 2019
First Posted
March 4, 2019
Study Start
November 7, 2018
Primary Completion
December 31, 2021
Study Completion
October 28, 2022
Last Updated
December 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share