Feasibility of Novel Laboratory Methods for Use in Nutrition Studies

Abbott Nutrition1 site in 1 country55 target enrollmentApril 2016

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Abbott Nutrition
Enrollment: 55
Locations: 1
Primary Endpoint: Comparison of lab values from venipuncture and DBS methods
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

September 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must agree to refrain from taking supplements other than study product.
•Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.

Exclusion Criteria

•Body Mass Index (BMI) \> or equal to 35 kg/m2
•Has planned elective surgery requiring 2 or more days of hospitalization during the entire study
•Has stated active malignant disease
•Has a known history of chronic renal parenchymal disease
•Has a known history of severe liver disease/liver failure
•Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures
•Known allergy or intolerance to any study product ingredient
•Participation in another study that has not been approved as a concomitant study

Outcomes

Primary Outcomes

Comparison of lab values from venipuncture and DBS methods

Time Frame: Baseline

Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards.