Phospholipids as Nutritional Support for Reduction of Anxiety
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Leeds Sleep Evaluation [1 week, 2 weeks, 3 weeks, 4 weeks]
Changes from baseline in sleep quality
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult people of any gender
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Age 18-75 years (inclusive)
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BMI between 18.0 and 34.0 (inclusive)
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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.
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Specific situations that occur regularly that cause anxiety, for example:
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Performing specific tasks at work or at home
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Inter-personal conflicts at work or at home
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Driving or commuting
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Fearful and worrying about one's own situation (such as paying bills)
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Worrying about ongoing problems experienced by others
Exclusion Criteria:
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Cancer during the past 12 months
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Chemotherapy during the past 12 months
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Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication
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Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product
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Food allergies or insensitivity related to lactose or other ingredients in test product
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People who are pregnant, nursing, or trying to become pregnant
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Natural Immune Systems Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 192-002