Novel Laboratory Methods in Nutrition Studies

Feasibility of Novel Laboratory Methods for Use in Nutrition Studies

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02732158

Enrollment

Registered

2016-04-08

Start date

2016-04-30

Completion date

2016-09-30

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Novel laboratory methods

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.

Interventions

OTHERNutrition Products

a sachet containing AN777and amino acids; a carotenoid capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026