Nutrition Beverage Tolerance Study

April 30, 2012 updated by: Abbott Nutrition
To evaluate the sensations experienced by subjects consuming a nutritional beverage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Livermore, California, United States, 94551
        • The National Food Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing neurologic adverse event(s)
Time Frame: 2-3 weeks
2-3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing any adverse event(s).
Time Frame: 2-3 Weeks
2-3 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Vikkie Mustad, PhD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • BK98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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