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Phospholipids as Nutritional Support for Reduction of Anxiety

N

Natural Immune Systems

Status

Not yet enrolling

Conditions

Anxiety

Treatments

Dietary Supplement: Milk-based phospholipids

Study type

Interventional

Funder types

Other

Identifiers

NCT05837832
192-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Experimental group
Experimental group
Description:
Participants will consume the dietary supplement every morning for 4 weeks.
Treatment:
Dietary Supplement: Milk-based phospholipids

Trial contacts and locations

0

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Central trial contact

Alex Cruickshank; Gitte S Jensen, PhD

Data sourced from clinicaltrials.gov

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