Phospholipids as Nutritional Support for Reduction of Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phospholipids as Nutritional Support for Reduction of Anxiety

Conditions
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Anxiety

Intervention / Treatment
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* Dietary Supplement: Milk-based phospholipids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |