Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)

What Was Tested

This registered phase 3 trial tested Sincalide.

The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate.

The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body.

It had four arms (groups): 1: Carb meal, fat meal, sincalide, placebo, urso (experimental), 2: Fat meal, carb meal, sincalide, placebo, urso (experimental), 3: Carb meal, fat meal, placebo, sincalide, urso (experimental) and 4: Fat meal, carb meal, placebo, sincalide, urso (experimental).

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 31 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Sincalide and who got the comparison, which limits bias.

Each person switched between Sincalide and the comparison at some point, usually with a gap in between.

As a double-blind Sincalide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-06-23 with completion listed for 2012-08-21.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Energy Expenditure (time frame: 6 hours). Bile Acid (time frame: 6 hours).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Sincalide in 31 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Sincalide compound page, all human trials.