NCT01464385

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

1 month

First QC Date

November 1, 2011

Last Update Submit

April 30, 2012

Conditions

Human Volunteers

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects experiencing neurologic adverse event(s)

    2-3 weeks

Secondary Outcomes (1)

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

    2-3 Weeks

Study Arms (3)

Nutritional Beverage #2

EXPERIMENTAL

Nutritional Beverage with an amino acid Oral 237 ml

Other: Nutritional Beverage

Nutritional Beverage #3

EXPERIMENTAL

Nutritional Beverage with an amino acid Oral 237 ml

Other: Nutritional Beverage

Nutritional Beverage #1

PLACEBO COMPARATOR

Nutritional Beverage Oral 237 ml

Other: Nutritional Beverage

Interventions

Nutritional BeverageOTHER

Nutritional Beverage Oral 237mL

Nutritional Beverage #1

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Food Lab

Livermore, California, 94551, United States

Location

Study Officials

  • Vikkie Mustad, PhD

    Abbott

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 3, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

US(1)