Phospholipids as Nutritional Support for Reduction of Anxiety

Not Applicable

Not yet recruiting

• Conditions: Anxiety

• Registration Number: NCT05837832
• Lead Sponsor: Natural Immune Systems Inc

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study Start: 2023-05
• Study First Posted: 2023-05-01
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
General Anxiety Disorder-7 (GAD-7) Questionnaire	1 week, 2 weeks, 3 weeks, 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire	1 week, 2 weeks, 3 weeks, 4 weeks	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.