Effects of quinine, alone and combined with dietary nutrients, on gut function and blood glucose in healthy volunteers

Not Applicable

Recruiting

• Conditions: increased energy intake; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12623000048684
• Lead Sponsor: Professor Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy

Exclusion Criteria

-regular gastrointestinal symptoms or significant gastrointestinal disease
-previous gastrointestinal surgery (other than gallbladder removal)
-use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (e.g. domperidone, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
-substantial daily consumption of quinine, e.g. as part of quinine-based anti-malaria treatment (irregular consumption of small amounts of quinine, e.g. in tonic water, is acceptable)
-regular medication that may affect any of the study outcomes (i.e. gastrointestinal motor or hormone function) and cannot be discontinued during the study
-using contraceptive pills, injections, IUD
-other food allergy
-current gallbladder or pancreatic disease
-coagulation abnormalities
-oesophageal varices or strictures
-cardiovascular or respiratory diseases that may affect any of the study outcomes and/or tolerance of the naso-duodenal tube
-all types of epilepsy
-individuals with low ferritin levels (females <15 ng/mL, males <30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
-any other illnesses as assessed by the investigator (including chronic illnesses that may affect any of the study outcomes and not explicitly listed above)
-high performance athletes, due to their specific dietary requirements and energy intakes (i.e. much higher than the average population), which affect gastrointestinal functions
-current intake of > 2 standard alcoholic drinks on > 5 days per week, due to the known effects of alcohol on gastrointestinal function
-current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping)
-recreational drug use (e.g. marijuana)
-current intake of any illicit substance (since all of these, i.e. tobacco products, marijuana and illicit drugs may affect gastrointestinal functions)
-vegetarians
-inability to tolerate naso-gastric tube
-inability to comprehend study protocol
-in premenopausal females, pregnancy, lactation or surgical sterilisation (a pregnancy test will be performed, using a urine sample, on the morning of study day
-female participants with self-reported irregular period cycles (since studies will be performed during the follicular phase, to avoid any influences of the different stages of the menstrual cycle on study outcomes)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy intake at the buffet meal measured using the computer software program FoodWorks.[ A buffet meal will be presented during each study visit (t = 0-30). The participants will be allowed to freely consume food until comfortably full for 30 minutes.]