Can Biotin Supplementation be Used to Mask hCG Abuse?

What Was Tested

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

This study is intended to measure: 1.

Urinary/serum hCG (human chorionic gonadotropin) and urinary biotin concentrations in both treatment groups before, during, and after hCG intervention using standard immunoassay methods 2.

It had two arms (groups): Cohort 1 (active comparator) and Cohort 2 (placebo comparator).

HCG plus biotin supplement.

HCG plus placebo supplement.

The registry classes the interventions as dietary supplement, drug and other.

More on the Plan

HCG, or human chorionic gonadotropin, is a protein hormone primarily produced in females by trophoblast cells during early pregnancy. hCG belongs to the glycoprotein hormone (GPH) family and exists as a heterodimer with an alpha and beta subunit.

Its beta subunit is unique to hCG, however, its alpha subunit is identical to that of other GPH family members, including luteinizing hormone (LH), follicular stimulating hormone (FSH), and thyroid stimulating hormone (TSH).

Due to this similarity to FSH and LH, it can be used as a female fertility treatment, however, hCG can also also stimulate the production of testosterone in the male testes and is sometimes used as a treatment for certain cases of hypogonadism.

Biotin interference is a well-known confounding factor in biotin-streptavidin immunoassays.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Participants must be healthy males aged 18 or older. Participants must be actively exercising individuals.

The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: individuals below the age of 18 or greater than the age of 55 on the day of enrollment; individuals unwilling to provide blood or urine samples; individuals that are not actively exercising.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2022-10-27 with completion listed for 2023-02-02.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: 1. Urinary hCG and biotin concentrations (time frame: 6 months). 2. HPT-related hormone measurements in serum; biotin measurements in serum (time frame: 6 months).

It also tracked 3 secondary outcomes, for example 1. Detection window of hCG following use, 2. Urinary testosterone/epitestosterone ratio measurement and 3. CBC measurements as they relate to the Athlete Biological Passport.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of hCG (human chorionic gonadotropin) in 10 people.

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

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.