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.

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.

Study Overview

• Status: Terminated
• Conditions: Helminthiasis
• Intervention / Treatment: Other: Control Food Product; Other: Novel Food Product

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais, Brazil
    • Centro de Pesquisas Rene Rachou-FIOCRUZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Food Product; Consumption of placebo food product	Other: Control Food Product; Control food product
Experimental: Novel Food Product; Consumption of novel food product	Other: Novel Food Product; Novel food product containing essential oil blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: TyraTech Technology
• Investigators: Principal Investigator: David Diemert, MD, FRCP(C), Rene Rachou Research Center, Brazil

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Helminthiasis
• Other Study ID Numbers: ABS-00-02