Nutrition Beverage Tolerance Study

Phase 2CompletedNCT01464385

Abbott Nutrition121 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

121

Conditions

Human Volunteers

Interventions

Nutritional BeverageOTHER

Nutritional Beverage Oral 237mL

Nutritional BeverageOTHER

Nutritional Beverage Oral 237 mL

Nutritional BeverageOTHER

Nutritional Beverage Oral 237mL

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The National Food Lab

Livermore, California, United States

Outcomes

Primary Outcomes

Proportion of subjects experiencing neurologic adverse event(s)

Time frame: 2-3 weeks

Secondary Outcomes

Proportion of subjects experiencing any adverse event(s).

Time frame: 2-3 Weeks

Data from ClinicalTrials.gov

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