Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.

What Was Tested

This registered early phase 1 trial tested Liraglutide.

To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.

It had two arms (groups): obese subjects (experimental) and lean subjects (no intervention).

Subjects will self-administer Liraglutide once daily for 12 weeks.

No intervention.

The registry classes the interventions as drug.

More on the Plan

Adolescents are the highest consumers of sugar sweetened beverages (SSB) potentially because their developing brains are most susceptible to the rewarding neural effects of sugar consumption.

Thus, the researchers specifically target this population (adolescents) to understand neural mechanisms involved in excess sugar consumption which predisposes to the development of obesity, prediabetes, and type 2 diabetes.

Upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration.

One of the secondary outcomes was removed because it was a duplicate of the second primary outcome.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 39 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 18-39 years old. Lean (BMI 18.5-24.9 kg/m2) with normoglycemia. Obese (BMI 30-45 kg/m2) with or without prediabetes. Able to read and write in English. Able to provide written and verbal informed consent.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: prior bariatric surgery or current gastric balloon; weight \>440lbs or waist circumference \>142cm; following a vegetarian/vegan diet or dieting/restricting food.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: participant.

It started in 2018-06-06 with completion listed for 2020-06-25.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages (time frame: 1 week). Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages (time frame: 1 week and 12 weeks).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Liraglutide in 13 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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