A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in a suppository on gastrointestinal hormone secretion and appetite in healthy humans.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000520033

Enrollment

Registered

2010-06-23

Start date

2010-07-05

Completion date

2010-09-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to establish whether taurocholic acid, administered as a suppository, can stimulate secretion of the gut peptides GLP-1, PYY, and oxyntomodulin, and suppress subsequent appetite and food intake. This information could be useful in designing treatments for type 2 diabetes and obesity.

Interventions

Each healthy volunteers will undergo four studies (3 with different doses of taurocholic acid 500mg, 1000mg, and 1500mg and one with control), in double-blind, randomised fashion, separated by 3 - 7 days. On each day the test material will be administered as a suppository.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Haemoglobin > 135 g/L

Exclusion criteria

Medications affecting gut function Alcohol intake >20g daily or cigarette smoking Significant gastrointestinal disease or surgery Impaired liver or renal function Blood donation within 3 months

Outcome results