Evaluation of the effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans

Completed

• Conditions: Obesity; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12610000113055
• Lead Sponsor: A/Prof Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Subjects will all be males between age 18 -56 years, with a body mass index (BMI) of 18 - 25 kg/m2 for lean, 25 - 30 kg/m2 for over-weight and between 30 -35 kg/m2 for obese. Lean subjects will be required to be unrestrained eaters. All other subjects would have to had consume less than 20g of alcohol per week, be non-smokers, free of gastrointestinal or chronic disease and not currently taking medication.

Exclusion Criteria

Each subject will be questioned prior to the study to exclude: (1)significant gastrointestinal symptoms; disease or surgery (2)current use of medications which may alter gastrointestinal motor function or appetite (3)diabetes mellitus (fasting glucose >6.9 mmol/l and/or glycated haemoglobin >6.2 %) (4)epilepsy (5)cardiovascular or respiratory disease (6)any other significant illness as assessed by the investigator (7)allergy to local anaesthetic (8)intake of > 20 g alcohol on a daily basis (9)smokers (10)individuals with food intolerances, allergies or vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intragastric meal distribution (ie the total stomach region and proximal and distal stomach regions). The mouth-to-caecum transit will be evaluated as the time from ingestion of the meal to the arrival of the head of the meal at the caecum. This was measured using scintigraphy[t = -15 min (baseline) and t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270 and 300 min]

Secondary Outcome Measures

Name	Time	Method
Appetite and hunger - Using visual analogue scale questionnaires[t = -15 min (baseline) and t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330 min after consumption of drink'];Hormone release - Cholecystokinin (CCK) and Peptide YY (PYY). Blood samples were drawn from subjects every 15 minutes until t=90, and then every 30 min from t = 90 - 300 min and then once more at t=330 after the buffet lunch. Radioimmunoassays were used to determine the concentration of these hormones in plasma.[t = -15 min (baseline) and t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330 min after consumption of drink'];Energy intake - At t = 300 min a cold buffet-style meal (t = 300 - 330 min). The meal will be weighted before and after consumption to for the assessment of energy intake using Foodwork[t = 300 min]