Phospholipids as Nutritional Support for Reduction of Anxiety

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety
• Intervention / Treatment: Dietary supplement: Milk-based phospholipids

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Cruickshank; Email: Alex@nislabs.com
• Study Contact Backup: Name: Gitte S Jensen, PhD; Phone Number: 541 882 0112; Email: Gitte@nislabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants will consume the dietary supplement every morning for 4 weeks.	Dietary supplement: Milk-based phospholipids; Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 192-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No