The metabolic effects of bitter taste sensing in the gut

Phase 1

Completed

• Conditions: Type 2 diabetes mellitus; Diet and Nutrition - Obesity; obesity; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618000093280
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-22
• Study Completion: 2019-03-29
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Healthy male and females aged 18 – 55 years
Body mass index (BMI) 19 - 25 kg/m2
Haemoglobin above the lower limit of the normal range (ie. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. >30ng/mL for men and >20mg/mL for women)

Exclusion Criteria

Use of any medication that may influence gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St. John's Wort etc.)
Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
Other significant illness, including epilepsy, cardiovascular or respiratory disease
Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal range))
Donation of blood within the previous 3 months
Participation in any other research studies within the previous 3 months
Inability to give informed consent
Female participants who are pregnant or planning for pregnancy, or are lactating
Vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
differences in the incremental area under the curve (iAUC) for plasma GLP-1 between the 5 treatments. [at t = 0, 15, 30, 45, 60, 75, 90 and 120min where t=0 is when rectal infusion started.]

Secondary Outcome Measures

Name	Time	Method
differences in the incremental area under the curve (iAUC) for plasma PYY between the 5 treatments.[at t = 0, 15, 30, 45, 60, 75, 90 and 120min where t=0 is when rectal infusion started.];differences in the incremental area under the curve (iAUC) for plasma glucose between the 5 treatments.[at t = 0, 15, 30, 45, 60, 75, 90 and 120min where t=0 is when rectal infusion started.];differences in the incremental area under the curve (iAUC) for gastrointestinal sensations, assessed by validated visual analogue scales, between the 5 treatments.[at t = 0, 15, 30, 45, 60, 75, 90 and 120min where t=0 is when rectal infusion started.];differences in energy intake from a standardised cold buffet meal between the 5 treatments.[t= 150min where t=0 is when rectal infusion started.]