Back to resultsPhospholipids as Nutritional Support for Reduction of Anxiety
Primary Purpose
Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Milk-based phospholipids
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Participants will consume the dietary supplement every morning for 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05837832
Brief Title
Phospholipids as Nutritional Support for Reduction of Anxiety
Official Title
Phospholipids as Nutritional Support for Reduction of Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natural Immune Systems Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants will consume the dietary supplement every morning for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk-based phospholipids
Intervention Description
Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.
Primary Outcome Measure Information:
Title
General Anxiety Disorder-7 (GAD-7) Questionnaire
Description
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.
Time Frame
1 week, 2 weeks, 3 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire
Description
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.
Time Frame
1 week, 2 weeks, 3 weeks, 4 weeks
Other Pre-specified Outcome Measures:
Title
Leeds Sleep Evaluation
Description
Changes from baseline in sleep quality
Time Frame
1 week, 2 weeks, 3 weeks, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte S Jensen, PhD
Phone
541 882 0112
Email
Gitte@nislabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Cruickshank
Email
Alex@nislabs.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Phospholipids as Nutritional Support for Reduction of Anxiety
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