NCT02717234

Brief Summary

To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 1, 2023

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

March 11, 2016

Last Update Submit

April 28, 2023

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Change in plasma arginine levels in µmol/L

    Pre-consumption, 30, 60, 120, 180, 240 minutes

Secondary Outcomes (2)

  • Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml

    Pre-consumption, 30, 60, 120, 180, 240 minutes

  • Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml

    Pre-consumption, 30, 60, 120, 180, 240 minutes

Other Outcomes (2)

  • Change in plasma-free phospholipid Docosahexaenoic acid (DHA) in µg/ml

    Pre-consumption, 30, 60, 120, 180, 240 minutes

  • Change in plasma phospholipid Docosahexaenoic acid (DHA) in µg/ml

    Pre-consumption, 30, 60, 120, 180, 240 minutes

Study Arms (2)

Impact Advanced Recovery

ACTIVE COMPARATOR

Oral nutrition supplement intended for consumption at 3 servings per day

Other: Oral Nutrition Supplement

Impact Advanced Recovery-R

EXPERIMENTAL

Oral nutrition supplement intended for consumption at 3 servings per day

Other: Oral Nutrition Supplement

Interventions

Oral Nutrition SupplementOTHER

Oral nutrition supplement intended for consumption at 3 servings per day

Impact Advanced RecoveryImpact Advanced Recovery-R

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)
  • Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing
  • Willing to provide signed informed consent

You may not qualify if:

  • Smoker
  • Patients with potential for non-compliance
  • Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)
  • Subject who in the Investigator's assessment cannot be expected to comply with study protocol
  • Currently participating in another conflicting clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sherwyn Schwartz, MD

    Diabetes & Glandular Disease Clinic, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 23, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 1, 2023

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share