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Nutrition Beverage Tolerance Study

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Abbott

Status and phase

Completed
Phase 2

Conditions

Human Volunteers

Treatments

Other: Nutritional Beverage

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

121 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

121 participants in 3 patient groups, including a placebo group

Nutritional Beverage #2
Experimental group
Description:
Nutritional Beverage with an amino acid Oral 237 ml
Treatment:
Other: Nutritional Beverage
Other: Nutritional Beverage
Other: Nutritional Beverage
Nutritional Beverage #3
Experimental group
Description:
Nutritional Beverage with an amino acid Oral 237 ml
Treatment:
Other: Nutritional Beverage
Other: Nutritional Beverage
Other: Nutritional Beverage
Nutritional Beverage #1
Placebo Comparator group
Description:
Nutritional Beverage Oral 237 ml
Treatment:
Other: Nutritional Beverage
Other: Nutritional Beverage
Other: Nutritional Beverage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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