Phospholipids as Nutritional Support for Reduction of Anxiety
- Conditions
- Anxiety
- Interventions
- Dietary Supplement: Milk-based phospholipids
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
- Arm && Interventions
Group Intervention Description Experimental group Milk-based phospholipids Participants will consume the dietary supplement every morning for 4 weeks.
- 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.