Phospholipids as Nutritional Support for Reduction of Anxiety

NCT05837832 | Unknown

• 1 other identifier: 192-002
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire

  1 week, 2 weeks, 3 weeks, 4 weeks

Other Outcomes (1)

• Leeds Sleep Evaluation

  1 week, 2 weeks, 3 weeks, 4 weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

Participants will consume the dietary supplement every morning for 4 weeks.

Dietary Supplement: Milk-based phospholipids

Interventions

Milk-based phospholipids DIETARY_SUPPLEMENT

Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Gitte S Jensen, PhD

CONTACT

541 882 0112; Gitte@nislabs.com

Alex Cruickshank

CONTACT

Alex@nislabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share