Effects of intraduodenal versus intragastric administration of quinine on gut function in healthy, lean volunteers.

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes; Healthy human gastrointestinal physiology; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619000707167
• Lead Sponsor: Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-10
• Study Completion: 2020-08-22
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Healthy
Lean weight (BMI 19-25 kg/m2)

Exclusion Criteria

Significant gastrointestinal symptoms, disease or surgery;
Current gallbladder or pancreatic disease;
Cardiovascular or respiratory diseases; .
Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above);
Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal 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.);
Individuals with low ferritin levels (less than 30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study;
Lactose intolerance/other food allergy(ies);
Vegetarians;
Restrained eaters (score >12 on the three factor eating questionnaire);
Current intake of greater than 2 standard drinks on greater than 5 days per week;
Current smokers of cigarettes/cigars/marijuana;
Current intake of any illicit substance;
High performance athletes;
Inability to comprehend study protocol;
Unable to tolerate naso-gastric tube

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of gluco-regulatory and gut hormones (Insulin, GLP-1, CCK, glucagon, ghrelin, PYY). <br>This outcome is of an exploratory nature so that specific gastrointestinal hormones to be measured may be decided upon based on the effect of the intervention on this and other outcomes, therefore, this is a composite outcome.[Samples will be collected at t = -10, 0 , 10, 20 , 30 , 45, 60 , 75 , 90, 120 min, where t = -10 is prior to quinine administration and t = 0 is immediately post-administartion. ];Antropyloroduodenal motility (number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure) will be measured using a 17-channel manometric assembly (Dentsleeve, Mui Scientific).<br>This outcome is of an exploratory nature so that specific motility parameters to be measured may be decided upon based on the effect of the intervention on this and other outcomes, therefore, this is a composite outcome.[Baseline (t = -10 - 0) and after administration (t = 0 -120). ]