Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had two arms (groups): HCG Group (experimental) and Saline/Placebo (placebo comparator).

This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.

This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.

The registry classes the interventions as drug and other.

More on the Plan

Four-week clinical trials were conducted on 59 females between the ages of 20 and 55, over an 18 month period.

All were placed on a VLCD resembling a protein-sparing modified fast.

Measured parameters: weight, body composition via bio-impedance, blood pressure, and blood labs.

A subset also underwent weekly electrocardiograms (EKG).

Who Took Part

59 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Body Mass Index (BMI) greater than 30,.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: complex medical history,; thyroid disease,; BMI less than 30,.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on hCG (human chorionic gonadotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2011-05 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet (time frame: 30 days).

It also tracked 1 secondary outcome, for example Muscle loss comparison between HCG and placebo group during a very low calorie diet.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of hCG (human chorionic gonadotropin) in 59 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.