Effects of Intragastric Quinine, Alone or Combined With L-isoleucine, on Postprandial Glycaemic Control
NCT05682339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-12-10
Summary
In this study, participants will receive, in randomized, double-blind fashion, an intragastric bolus administration of either (i) 300 mg quinine, (ii) 5 g L-isoleucine, (iii) a combination of (i)+(ii), or (iv) control, before 350 ml (500 kcal) of a mixed-nutrient drink, to evaluate the effects on postprandial blood glucose, gastric emptying, and the hormone, and appetite, responses to the mixed-nutrient drink. Study visits will be separated by 3-7 days and participants will receive one treatment per visit.
On each study visit, the participant will be intubated with a nasogastric feeding tube. At t= - 60 min (08:30 am), a baseline blood sample, visual analogue scale questionnaire (VAS), and breath sample will be collected and quinine or control will be administered through the feeding tube. 30 min later (at t= - 30 min), L-isoleucine or control will be administered over 2 min after which the feeding tube will be removed immediately. At t = -45, -30, -15, and -1 min further blood samples will be collected and VAS completed. At t = -1 min, participants will consume, within 1 minute, a mixed-nutrient drink, labeled with 100 mg of 1-13C-acetate for measurement of gastric emptying by breath sampling. Blood samples, VAS, and breath samples will be taken at regular intervals between t = 0-180 min.
Conditions
- Healthy
Interventions
- OTHER
-
Quinine
Quinine, which is a bitter compound, extracted from the bark of the cinchona tree and has been shown in our previous studies to lower blood glucose in doses of 300-600 mg, will be 'active' in this condition.
- OTHER
-
L-isoleucine
L-isoleucine, which is a branched-chain amino acid, and one of the building blocks of protein, therefore is part of our daily diet, will be 'active' in this condition.
- OTHER
-
Combination of quinine and L-isoleucine
In this condition, both quinine and L-isoleucine will be administered as 'active'.
- OTHER
-
Control
In the condition, where quinine is 'active', control for L-isoleucine (5 ml oraplus and 95 ml saline) will be administered. In the condition, where L-isoleucine will be 'active', control for quinine (10 ml distilled water) will be administered. Whereas, in a control condition, both for quinine and L-isoleucine, a control solution will be administered.
Sponsors & Collaborators
-
University of Adelaide
lead OTHER
Principal Investigators
-
Christine Feinle-Bisset, PhD · University of Adelaide, Adelaide, South Australia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-19
- Primary Completion
- 2024-06-24
- Completion
- 2024-06-24
Countries
- Australia
Study Locations
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