Effects of Combined Administration of Calcium and L-tryptophan on Gut Functions and Blood Glucose in Healthy Humans

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-70
SponsorUniversity of Adelaide

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy, lean males (only men will be included in the study to avoid the confounding effects of the menstrual cycle on gastric emptying).

BMI: 19-25 kg/m2,

Weight-stable (i.e. <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 3 months.

Disqualifiers

Significant GI symptoms, or history of GI 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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • L-tryptophan

    Other intervention

    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.

  • Combination of L-tryptophan + Ca-500

    Other intervention

    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'.

  • Combination of L-tryptophan + Ca-1000

    Other intervention

    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'.

  • Control

    Other intervention

    An isotonic solution containing 2.5 g of NaCl, dissolved in 225 mL of distilled water.

Treatment groups

16 Participants
are divided into 4 treatment groups
Group A: L-tryptophanActive comparator 1 intervention
Group B: L-tryptophan + Ca-500Active comparator 1 intervention
Group C: L-tryptophan + Ca-1000Active comparator 1 intervention
Group D: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Plasma glucose concentrations

Plasma glucose concentrations (mmol/L) will be assessed using the glucose oxidase method.

Time frame
Blood samples will be collected over 4.5 hours: at baseline (time = -30 minutes), then at regular intervals before and after drink administration (times = -25, -15, 0, 10, 20, 30, 45, 60, 75, 90, 120, 180, and 240 minutes).

Secondary outcomes

1

Gastric emptying

13C-acetate breath test, measuring 13CO2 levels in end-expiratory breath samples.

Time frame
Breath samples will be collected in sealed tubes over 4.5 hours: at baseline (time = -30 minutes), prior to treatment administration, every 5 minutes after the drink (times = 0 to 60 minutes), and then every 10 minutes until 240 minutes post-drink.
2

Plasma concentrations of glucoregulatory hormones e.g. glucagon-like peptide (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), C-peptide, glucagon, insulin and cholecystokinin (CCK)

Plasma concentrations of hormones e.g. GLP-1, GIP and CCK (pmol/L) will be determined using radioimmunoassays, and plasma C-peptide, glucagon and insulin concentrations (pmol/L) will be measured using ELISA immunoassays.

Time frame
Blood samples will be collected over 4.5 hours: at baseline (time = -30 minute), then at regular intervals before and after the drink (times = -25, -15, 0, 10, 20, 30, 45, 60, 75, 90, 120, 180, and 240 minutes).
3

GI symptoms (nausea and bloating) will be assessed as a composite secondary outcome.

These will be measured using 100mm VAS questionnaires.

Time frame
VAS questionnaires will be collected over 4.5 hours: at baseline (time = -30 minutes), at regular intervals before and after the drink (times = -15, 0, 10, 20, 30, 45, 60, 75, and 90 minutes), then every 10 minutes until 240 minutes post-drink.

Other outcomes

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