Clinical trial NCT05837832: Phospholipids as Nutritional Support for Reduction of Anxiety
Official title: Phospholipids as Nutritional Support for Reduction of Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: General Anxiety Disorder-7 (GAD-7) Questionnaire
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes:
measure: Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
Other outcomes:
measure: Leeds Sleep Evaluation
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
Locations:
Study officials:
References: