None listed
Conditions
Brief summary
To compare in healthy, lean individuals the effects of (1) the three macronutrients, carbohydrate, protein and fat, (2) combinations of lipid and protein, on antropyloroduodenal motility, gut hormone release, appetite and energy intake.
Interventions
Study 1 and Study 2 will be conducted seperately and consist of different volunteers.
Subjects within each study will undergo 5 treatments, in double-blind, randomised, cross over fashion. Gastrointestinal (GI) motility, hormone release, appetite and energy intake will be evaluated. The nutrient infusions will be administered for 120 min at a rate of 3 kcal/min, corresponding to the average rate of postprandial gastric emptying treatments. Treatments within each study will be separated by 7-10
Study 1 and Study 2 will be conducted seperately and consist of different volunteers. Subjects within each study will undergo 5 treatments, in double-blind, randomised, cross over fashion. Gastrointestinal (GI) motility, hormone release, appetite and energy intake will be evaluated. The nutrient infusions will be administered for 120 min at a rate of 3 kcal/min, corresponding to the average rate of postprandial gastric emptying treatments. Treatments within each study will be separated by 7-10 days. Study 1 will evalutate: i) lipid ii) carbohydrate iii) protein iv) macronutrient combination of lipid:carbohydrate:protein (30:50:20) v) saline control Study 2 will evaluate: i) lipid ii) protein iii) protein:lipid (2:1) iv) protein:lipid (1:2) v) saline control
Sponsors
A/Prof Christine Feinle-Bisset
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Outcome results
None listed