Effects of Combined Administration of Calcium and L-tryptophan on Gut Functions and Blood Glucose in Healthy Humans
NCT07013656 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-06-24
Summary
The intervention in this study consists of 75-minute intraduodenal infusions of isosmotic solutions containing either saline (control), L-tryptophan, or calcium combined with L-tryptophan. Participants enrolled into the study will receive, in a randomised, double-blind fashion either (i) saline (control), (ii) L-tryptophan at a rate of 0.1 kcal/minute, (iii) combination of L-tryptophan (0.1 kcal/minute) + 500 mg calcium, or (iv) combination of L-tryptophan (0.1 kcal/minute) + 1000 mg calcium in four separate sessions, each of which will be separated by at least 4 (and up to 10) days. Each study session will be 4-6 hours. Studies will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide, by staff and students trained in the required techniques.
Conditions
- Healthy
Interventions
- OTHER
-
L-tryptophan
L-tryptophan, an aromatic amino acid and one of the building blocks of protein, is a part of our daily diet. The load of L-tryptophan (0.1 kcal/minute) is based on our previous study, in which L-tryptophan represented a submaximal load.
- OTHER
-
Combination of L-tryptophan + Ca-500
Calcium, an essential mineral and a key component of dairy products, is a regular part of our daily diet. In this condition, both L-tryptophan and calcium will be administered as 'active'. Recent studies have shown that calcium in a dose of 500 mg enhances the effects of L-tryptophan to stimulate gut functions and reduce energy intake. This dose of calcium will be considered 'lower dose'.
- OTHER
-
Combination of L-tryptophan + Ca-1000
In this condition, both L-tryptophan and calcium will be administered. In our study calcium in a dose of 1000 mg enhances the effects of L-tryptophan to stimulate gut functions and reduce energy intake. This dose of calcium will be considered 'higher dose'.
- OTHER
-
Control
An isotonic solution containing 2.5 g of NaCl, dissolved in 225 mL of distilled water.
Sponsors & Collaborators
-
University of Adelaide
lead OTHER
Principal Investigators
-
Prof Christine Feinle-Bisset · Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-28
- Primary Completion
- 2026-06-28
- Completion
- 2026-11-25
Countries
- Australia
Study Locations
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