Phospholipids as Nutritional Support for Reduction of Anxiety

NCT ID: NCT05837832

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Participants will consume the dietary supplement every morning for 4 weeks.

Group Type: EXPERIMENTAL

Milk-based phospholipids

Intervention Type: DIETARY_SUPPLEMENT

Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.

Interventions

Milk-based phospholipids

Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Immune Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gitte S Jensen, PhD

Role: CONTACT

Gitte@nislabs.com

541 882 0112

Alex Cruickshank

Role: CONTACT

Alex@nislabs.com

Other Identifiers

192-002

Identifier Type: -

Identifier Source: org_study_id