Novel Laboratory Methods in Nutrition Studies
Feasibility of Novel Laboratory Methods for Use in Nutrition Studies
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
April 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 27, 2017
March 1, 2017
5 months
April 4, 2016
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in AN777
Baseline to Day 60
Change in carotenoids
Baseline to Day 60
Compliance of study product consumption
Baseline to Day 60
Study Arms (1)
Nutrition Products
EXPERIMENTALTwo servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day
Interventions
a sachet containing AN777and amino acids; a carotenoid capsule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
Texas A&M University, Center for Translation Research in Aging and Longevity
College Station, Texas, 77843-4253, United States
Study Officials
- STUDY CHAIR
Carolyn Alish, PhD, RD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
April 8, 2016
Study Start
April 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
March 27, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share