An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths

A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271049

Enrollment

Registered

2011-01-06

Start date

2011-01-31

Completion date

2012-02-29

Last updated

2012-12-12

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

Conditions

Helminthiasis

Brief summary

The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.

Interventions

OTHERNovel Food Product

Novel food product containing essential oil blend

OTHERControl Food Product

Control food product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Male or Female adults, age 18-45 years old inclusive on date of screening * Showing presence of no or mild-moderate helminths

Exclusion criteria

* Presence of heavy helminth load * Pregnant or lactating * Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine

Design outcomes

Primary

Measure	Time frame	Description
Measure of Safety and Tolerability using the Reactogenicity Questionairre	43 days	Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters.

Countries

Brazil

Outcome results

None listed

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