Comparative effects of intraduodenal macronutrients, carbohydrate, lipid and protein, and combinations of lipid and protein, on gut motility, hormones, appetite and energy intake in lean subjects

Recruiting

• Conditions: To compare in healthy, lean individuals the effects of the three macronutrients, carbohydrate, protein and fat, on antropyloroduodenal motility, gut hormone release, appetite and energy intake.; To compare in healthy, lean individuals the effects of combinations of lipid and protein, on antropyloroduodenal motility, gut hormone release, appetite and energy intake.; To compare in healthy, lean individuals the effects of combinations of lipid and protein,; on antropyloroduodenal motility, gut hormone release, appetite and energy intake.; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12609000949280
• 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: 2009-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Subjects will all be healthy males between age 18 -55 years, with a body mass index (BMI) of 18 - 25 kg/m2. 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 GI symptoms; disease or surgery
(2)current use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
(3)diabetes mellitus
(4)individuals with low blood iron levels
(5)epilepsy
(6)cardiovascular or respiratory disease
(7)any other significant illness as assessed by the investigator
(8)allergy to local anaesthetic
(9)intake of > 20 g alcohol on a daily basis
(10)smokers (cigarettes/cigars/marijuana)
(11)unrestrained eaters, as determined by a score of =12 on the eating restraint questionnaire component of the eating questionnaire.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antropyloroduodenal motility - During the 120 minute infusion antropyloduodenal motility was assessed via changes in the pressures within specific portion of the gastrointestinal tract (antrum, pylorus and duodenum) which was captured by sensors on the catheter, and connected to a computer-based system, running commercially available hardware (Flexisoft)[-15, 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes]

Secondary Outcome Measures

Name	Time	Method
Appetite and hunger - Using visual analogue scale questionnaires[-15, 0, 15, 30, 45, 60, 75, 90, 120 and 150 minutes];Hormone release - Cholecystokinin (CCK) and Peptide YY (PYY). Blood samples were drawn from subjects every 15 minutes until t=90, and then once more at t=120. Radioimmuno assays were used to determine the concentration of these hormones in plasma.[-15, 0, 15, 30, 45, 60, 75, 90, 120 and 150 minutes];Energy intake - At t = 120 min the infusion will be discontinued, and the subject extubated and offered a cold buffet-style meal (t = 120 - 150 min). The meal will be weighted before and after consumption to for the assessment of energy intake using Foodwork[120 minutes]