Novel Laboratory Methods in Nutrition Studies

NCT ID: NCT02732158

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nutrition Products

Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day

Group Type EXPERIMENTAL

Nutrition Products

Intervention Type OTHER

a sachet containing AN777and amino acids; a carotenoid capsule

Interventions

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Nutrition Products

a sachet containing AN777and amino acids; a carotenoid capsule

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn Alish, PhD, RD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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

College Station, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BL27

Identifier Type: -

Identifier Source: org_study_id

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