Novel Laboratory Methods in Nutrition Studies

Feasibility of Novel Laboratory Methods for Use in Nutrition Studies

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Nutrition Products

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843-4253
      • Texas A&M University, Center for Translation Research in Aging and Longevity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition Products; Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day	Other: Nutrition Products; a sachet containing AN777and amino acids; a carotenoid capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in AN777		Baseline to Day 60
Change in carotenoids		Baseline to Day 60
Compliance of study product consumption	Subject Questionnaire	Baseline to Day 60

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Carolyn Alish, PhD, RD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Novel laboratory methods
• Other Study ID Numbers: BL27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO