Phospholipids as Nutritional Support for Reduction of Anxiety

Anxiety Clinical Trial

Official title:

Phospholipids as Nutritional Support for Reduction of Anxiety

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05837832
• Other study ID #: 192-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Natural Immune Systems Inc
• Contact: Gitte S Jensen, PhD
• Phone: 541 882 0112
• Email: Gitte[@]nislabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Dietary Supplement:
• Milk-based phospholipids
Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Leeds Sleep Evaluation	Changes from baseline in sleep quality	1 week, 2 weeks, 3 weeks, 4 weeks
Primary	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.	1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	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.	1 week, 2 weeks, 3 weeks, 4 weeks