Phospholipids as Nutritional Support for Reduction of Anx... | NCT05837832

Studies
Phospholipids as Nutritional Support for Reduction of Anxiety

NCT05837832

Sponsor

Natural Immune Systems Inc

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Anxiety

Interventions

Milk-based phospholipids

Countries

Not provided

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2023Estimated

Primary Completion Date

Aug 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Apr 20, 2023

First Submission Date that Met QC Criteria

Apr 20, 2023

First Posted Date

May 1, 2023Actual

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

May 8, 2023

Last Update Posted Date

May 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The goal of this clinical trial is to learn about the effects of a milk-based dietary supplement in adults that report regular and frequent episodes of intermittent anxiety. The main question it aims to answer is: Can this extract be used to reduced symptoms of intermittent anxiety?

Participants will consume the milk-based dietary supplement every morning for 4 weeks and each week they will fill out 3 different questionnaires.

Detailed Description

Clinical study evaluating the effects of a dietary milk-based supplement to help reduce symptoms of anxiety. The milk-based supplement is a fat-rich fraction of whey, rich in phospholipids.

24 subjects who report frequent and regular episodes of intermittent anxiety will participate in a questionnaire based clinical trial, wherein they will be consuming the milk-based dietary supplement each morning for 4 weeks.

Each week subjects will fill out 2 questionnaires evaluating their anxiety and 1 questionnaire evaluating their sleep. Changes in stress will be measured relative to baseline scores, collected during the first week before supplement consumption.

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	Participants will consume the dietary supplement every morning for 4 weeks.	Dietary Supplement: Milk-based phospholipids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milk-based phospholipids	Dietary Supplement	Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
General Anxiety Disorder-7 (GAD-7) Questionnaire	Change from baseline in anxiety score using the General Anxiety Disorder 7-item. The General Anxiety Disorder-7 scale evaluates anxiety severity using scores ranging from 0-21, higher scores indicate higher anxiety severity, a worse outcome.	1 week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire	Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) score. The Overall Anxiety Severity and Impairment scale evaluates anxiety and fear in participants with a score between 0 and 25, higher scores indicate higher anxiety severity, a worse outcome.	1 week, 2 weeks, 3 weeks, 4 weeks

Other Outcomes

Measure	Description	Time Frame
Leeds Sleep Evaluation	Changes from baseline in sleep quality	1 week, 2 weeks, 3 weeks, 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult people of any gender
Age 18-75 years (inclusive)
BMI between 18.0 and 34.0 (inclusive)
Experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations.
Specific situations that occur regularly that cause anxiety, for example:
Performing specific tasks at work or at home
Inter-personal conflicts at work or at home
Driving or commuting
Fearful and worrying about one's own situation (such as paying bills)
Worrying about ongoing problems experienced by others

Exclusion Criteria:

Cancer during the past 12 months
Chemotherapy during the past 12 months
Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication
Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product
Food allergies or insensitivity related to lactose or other ingredients in test product
People who are pregnant, nursing, or trying to become pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Gitte S Jensen, PhD	Contact	541 882 0112		Gitte@nislabs.com
Alex Cruickshank	Contact			Alex@nislabs.com

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