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OpenTrials
Completed

NCT Number: NCT02732158

Novel Laboratory Methods 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.

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Key information

Conditions

Healthy

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M University, Center for Translation Research in Aging and Longevity

College Station, Texas, 77843-4253, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Products

Other

a sachet containing AN777and amino acids; a carotenoid capsule

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in AN777

    Time frame: Baseline to Day 60

  2. Change in carotenoids

    Time frame: Baseline to Day 60

  3. Compliance of study product consumption

    Time frame: Baseline to Day 60

    Subject Questionnaire

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Feasibility of Novel Laboratory Methods for Use in Nutrition Studies

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2016
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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