Nutrition Beverage Tolerance Study

• Sponsor: Abbott Nutrition (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01464385
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 60.4

Study Details

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; Other: Nutritional Beverage; Other: Nutritional Beverage	Phase 2

Study Design

• Study Type: Interventional
• 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: Oct 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 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) [2-3 weeks]

Secondary Outcome Measures

1. Proportion of subjects experiencing any adverse event(s). [2-3 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	The National Food Lab	Livermore	California	United States	94551

Sponsors and Collaborators

• Abbott Nutrition

Investigators

• Study Chair: Vikkie Mustad, PhD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Nutrition
• ClinicalTrials.gov Identifier: NCT01464385
• Other Study ID Numbers: BK98
• First Posted: Nov 3, 2011
• Last Update Posted: May 1, 2012
• Last Verified: Apr 1, 2012

Study Results

No Results Posted as of May 1, 2012