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

NCT ID: NCT01271049

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Helminthiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Food Product

Consumption of placebo food product

Group Type PLACEBO_COMPARATOR

Control Food Product

Intervention Type OTHER

Control food product

Novel Food Product

Consumption of novel food product

Group Type EXPERIMENTAL

Novel Food Product

Intervention Type OTHER

Novel food product containing essential oil blend

Interventions

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Novel Food Product

Novel food product containing essential oil blend

Intervention Type OTHER

Control Food Product

Control food product

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TyraTech Technology

UNKNOWN

Sponsor Role collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Diemert, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Rene Rachou Research Center, Brazil

Locations

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Centro de Pesquisas Rene Rachou-FIOCRUZ

Minas Gerais, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ABS-00-02

Identifier Type: -

Identifier Source: org_study_id