Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabloc on Antithyroid Autoantibodies and Thyroid Function in Autoimmune Thyroiditis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01551498

Acronym

ASAP

Enrollment

165

Registered

2012-03-12

Start date

2012-03-31

Completion date

2013-02-28

Last updated

2015-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroiditis, Autoimmune

Keywords

Hashimoto Disease, Thyroiditis

Brief summary

This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.

Detailed description

This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.

Interventions

DIETARY_SUPPLEMENTAnatabloc Supplement

Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day

DIETARY_SUPPLEMENTPlacebo

Placebo, as mint flavored lozenges, to be taken 3 times each day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* adults 18-70 years of age * having positive antibodies against thyroid peroxidase * having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis

Exclusion criteria

* having evidence of end-stage thyroiditis * being a current smoker or smokeless tobacco user * be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody * be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent

Design outcomes

Primary

Measure	Time frame	Description
Numbers of subjects experiencing adverse effects as a measure of safety	3 months	Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects

Secondary

Measure	Time frame	Description
Measured changes in markers of autoimmune thyroiditis: changes in blood levels of anti-thyroid auto-antibodies, and changes in the volume and vascularization of the thyroid	3 months	To determine if dietary supplementation with Anatabloc has an effect on antithyroid autoantibody levels, thyroid structure, and/or thyroid function in subjects with autoimmune thyroiditis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026