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

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ClinicalTrials.gov Identifier: NCT01271049
Recruitment Status : Terminated (Due to a business decision to stop the project, the study was terminated early.)
First Posted : January 6, 2011
Last Update Posted : December 12, 2012
Sponsor:
Collaborator:
TyraTech Technology
Information provided by (Responsible Party):
Mondelēz International, Inc.

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.

Condition or disease Intervention/treatment Phase
Helminthiasis Other: Novel Food Product Other: Control Food Product Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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.
Study Start Date : January 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Measure of Safety and Tolerability using the Reactogenicity Questionairre [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271049


Locations
Brazil
Centro de Pesquisas Rene Rachou-FIOCRUZ
Minas Gerais, Brazil
Sponsors and Collaborators
Mondelēz International, Inc.
TyraTech Technology
Investigators
Principal Investigator: David Diemert, MD, FRCP(C) Rene Rachou Research Center, Brazil

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01271049     History of Changes
Other Study ID Numbers: ABS-00-02
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Helminthiasis
Parasitic Diseases