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OpenTrials
Completed

NCT Number: NCT01464385

Nutrition Beverage Tolerance Study

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

Completed

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Key information

Conditions

Human Volunteers

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The National Food Lab

Livermore, California, 94551, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Beverage

Other

Nutritional Beverage Oral 237mL

Primary outcomes

  1. Proportion of subjects experiencing neurologic adverse event(s)

    Time frame: 2-3 weeks

Secondary outcomes

  1. Proportion of subjects experiencing any adverse event(s).

    Time frame: 2-3 Weeks

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2011
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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