Nutrition Beverage Tolerance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01464385
First received: November 1, 2011
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Human Volunteers
Other: Nutritional Beverage
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition Beverage Tolerance Study

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Proportion of subjects experiencing neurologic adverse event(s) [ Time Frame: 2-3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects experiencing any adverse event(s). [ Time Frame: 2-3 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 121
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01464385     History of Changes
Other Study ID Numbers: BK98
Study First Received: November 1, 2011
Last Updated: April 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014