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A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in an enema formulation on gastrointestinal hormone secretion and appetite in healthy humans for the future design of treatments for Type 2 diabetes mellitus and obesity

A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in an enema formulation on gastrointestinal hormone secretion and appetite in healthy humans for the future design of treatments for Type 2 diabetes mellitus and obesity

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000071921
Enrollment
12
Registered
2011-01-19
Start date
2011-03-02
Completion date
2011-05-03
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 an enema, 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 three treatments (2 with different doses of taurocholic acid 1500mg and 3500mg and one with control), in double-blind, randomised fashion, separated by 3 - 7 days. On each day the test material will be administered as an enema, and each session will last 210 min.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

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

Healthy subjects; Body mass index (BMI) 19 - 30 kg/m2; 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

None listed

Source: ANZCTR · Data processed: Feb 4, 2026