Anxiety
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMilk-based phospholipids
Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.
Sponsors
Natural Immune Systems Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Leeds Sleep Evaluation | 1 week, 2 weeks, 3 weeks, 4 weeks | Changes from baseline in sleep quality |
Contacts
Primary ContactGitte S Jensen, PhD
Backup ContactAlex Cruickshank
Outcome results
None listed