Effects of acute and longer-term energy restriction in lean and obese subjects on gut motility, hormones, appetite and energy intake in response to small intestinal nutrients and on oral fat perceptio

Recruiting

• Conditions: Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Investigate the effects of prolonged (3 months) energy restriction on GI function, appetite and weight loss in obese subjects,in response to duodenal nutrients.; Investigate the effects of prolonged (3 months) energy restriction on GI function, appetite and weight loss in obese subjects,; Investigate the effects of acute (4 days) energy restriction on gastrointestinal (GI) function and appetite, in both lean and obese subjects.; in response to duodenal nutrients.; Diet and Nutrition - Obesity

• Registration Number: ACTRN12609000943246
• 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: 2009-11-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Subjects will all be males between age 18 -55 years, with a body mass index (BMI) of 18 - 25 kg/m2 for lean and between 30 -35 kg/m2 for obese. Lean subjects will be required to be unrestrained eaters, 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
Antropyloroduodenal motility -<br>During the 120 minute infusion antropyloduodenal motility will be assessed via changes in the pressures within the antrum, pylorus and duodenum which are captured by sensors on the catheter, and connected to a computer-based system, running commercially available hardware (Flexisoft)[At -15, 0, 15, 30, 45, 60, 75, 90, 120 min during the infusion period on each study day.<br>Study days for:<br>Obese - days 1 and 4 and weeks 4 and 12<br>Lean - days 1 and 4]