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

This study has been terminated.
(Due to a business decision to stop the project, the study was terminated early.)
Sponsor:
Collaborator:
TyraTech Technology
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01271049
First received: January 3, 2011
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 Intervention
Helminthiasis
Other: Novel Food Product
Other: Control Food Product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:
  • Measure of Safety and Tolerability using the Reactogenicity Questionairre [ Time Frame: 43 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 45
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01271049     History of Changes
Other Study ID Numbers: ABS-00-02
Study First Received: January 3, 2011
Last Updated: December 11, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on August 20, 2014