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

Helminthiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01271049
• Other study ID #: ABS-00-02
• Status: Terminated
• Phase: N/A
• First received: January 3, 2011
• Last updated: December 11, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Helminthiasis

Intervention

Other:
• Novel Food Product
Novel food product containing essential oil blend
• Control Food Product
Control food product

Locations

Country	Name	City	State
Brazil	Centro de Pesquisas Rene Rachou-FIOCRUZ	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	TyraTech Technology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Safety and Tolerability using the Reactogenicity Questionairre	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.	43 days	Yes