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Nutrition Beverage Tolerance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01464385
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the sensations experienced by subjects consuming a nutritional beverage.

Condition or disease Intervention/treatment Phase
Human Volunteers Other: Nutritional Beverage Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition Beverage Tolerance Study
Study Start Date : October 2011
Primary Completion Date : November 2011
Study Completion Date : December 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: Nutritional Beverage #2
Nutritional Beverage with an amino acid Oral 237 ml
Other: Nutritional Beverage
Nutritional Beverage Oral 237 mL
Experimental: Nutritional Beverage #3
Nutritional Beverage with an amino acid Oral 237 ml
Other: Nutritional Beverage
Nutritional Beverage Oral 237mL
Placebo Comparator: Nutritional Beverage #1
Nutritional Beverage Oral 237 ml
Other: Nutritional Beverage
Nutritional Beverage Oral 237mL


Outcome Measures

Primary Outcome Measures :
  1. Proportion of subjects experiencing neurologic adverse event(s) [ Time Frame: 2-3 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects experiencing any adverse event(s). [ Time Frame: 2-3 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations

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): NCT01464385


Locations
United States, California
The National Food Lab
Livermore, California, United States, 94551
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Vikkie Mustad, PhD Abbott
More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01464385     History of Changes
Other Study ID Numbers: BK98
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012