Novel Laboratory Methods in Nutrition Studies | NCT02732158

Studies
Novel Laboratory Methods in Nutrition Studies

NCT02732158

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Mar 27, 2017Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Nutrition Products

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Apr 4, 2016

First Submission Date that Met QC Criteria

Apr 7, 2016

First Posted Date

Apr 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2017

Last Update Posted Date

Mar 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrition Products	Experimental	Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day	Other: Nutrition Products

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrition Products	Other	a sachet containing AN777and amino acids; a carotenoid capsule	Nutrition Products

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolyn Alish, PhD, RD	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas A&M University, Center for Translation Research in Aging and Longevity		College Station	Texas	77843-4253	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided