How do interactions between oral and small intestinal exposure to oleic acid influence gastrointestinal function in healthy lean and obese participants

Not Applicable

Recruiting

• Conditions: Obesity; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12609001074280
• Lead Sponsor: Dr Tanya Little

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Equal numbers of healthy male and female subjects, 15 of normal body weight for their height (body mass index (BMI): 19 - 25 kg/m2), and 15 obese (BMI 30 – 35 kg/m2), aged 18-55 years. Subjects will need to be unrestrained eaters, non-smokers, and for female subjects will be required to be taking an appropriate hormonal contraceptive.

Exclusion Criteria

(1)significant gastrointestinal 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 (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St John's Wort etc.)
(3)diabetes mellitus
(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 (cigarettes, cigars, marijuana)
(10)in female subjects, pregnancy or lactation. A pregnancy test will be performed in all female subjects, using a urine sample, prior to commencement of the study and subsequently prior to each study day
(11)restrained eaters, as determined by a score of >12 on the eating restraint questionnaire component of the eating questionnaire (35). However, while the degree of eating restraint will be assessed and recorded in the obese subjects, this will not be used as an exclusion criteria, as the majority of obese subjects are likely to have some degree of eating restraint.
(12)donation of blood in the 12 weeks prior to enrolment in the study. Subjects will also be instructed to abstain from donating blood for 12 weeks after study completion
(13)low iron levels
(14)consumption of a vegetarian diet

Study & Design

• Study Type: Interventional
• Study Design: Not specified