Novel Laboratory Methods in Nutrition Studies

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Nutrition Products

• Registration Number: NCT02732158
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutrition Products	Nutrition Products	Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day

Primary Outcome Measures

Name	Time	Method
Comparison of lab values from venipuncture and DBS methods	Baseline	Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards.

Secondary Outcome Measures

Name	Time	Method
Change in carotenoids	Baseline to Day 60
Change in AN777	Baseline to Day 60
Compliance of study product consumption	Baseline to Day 60	Subject Questionnaire

Trial Locations

Locations (1)

Texas A&M University, Center for Translation Research in Aging and Longevity; 🇺🇸 College Station, Texas, United States