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NCT01464385 Clinical Trial

Nutrition Beverage Tolerance Study

Human Volunteers Clinical Trial

Official title:
Nutrition Beverage Tolerance Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01464385
Other study ID # BK98
Secondary ID
Status Completed
Phase Phase 2
First received November 1, 2011
Last updated April 30, 2012
Start date October 2011
Est. completion date December 2011

Study information
Verified date April 2012
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To evaluate the sensations experienced by subjects consuming a nutritional beverage.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

Subject = 45 years of age.

If female, subject is either postmenopausal for at least 1 year or surgically sterile

Subject reports that he/she has not participated in a research study in the last three months.

Exclusion Criteria:

Subject has active metabolic or endocrine disease

Subject has an autoimmune disorder

Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.

Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products

Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Nutritional Beverage
Nutritional Beverage Oral 237mL
• Nutritional Beverage
Nutritional Beverage Oral 237 mL
• Nutritional Beverage
Nutritional Beverage Oral 237mL

Locations
Country Name City State
United States The National Food Lab Livermore California

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects experiencing neurologic adverse event(s) 2-3 weeks Yes
Secondary Proportion of subjects experiencing any adverse event(s). 2-3 Weeks Yes
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