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Investigating the Effects of Dairy Phospholipids on Sleep and Daytime Function in Healthy Adults.

NCT06663865 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-29

No results posted yet for this study

Summary

The aim of the study is to investigate the effects of 6- and 12- week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on sleep and daytime function parameters in healthy adults.

The proposed randomised, double-blind, placebo-controlled parallel groups design methodology will assess the sleep and daytime function effects (both self-reported and physiological) of 40g per day of bioactive whey protein concentrate in the form of a powder that the participant will be required to mix with 350ml of water and matched placebo prior to (baseline) and after -6 week and -12 week supplementation. The trial will utilise actigraphy sleep watches and online cognitive assessments alongside saliva sampling, sleep diaries, and self-report questionnaires as measures of the outcome variables.

70 participants will participate, aged 25-49, and self-reported as being in good health. Participants will be supplied with either the active treatment or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

Conditions

  • Sleep
  • Morning Alertness
  • Evening Alertness
  • Diurnal Cortisol

Interventions

DIETARY_SUPPLEMENT

Active

40g bio-active whey protein concentrate powder containing dairy phospholipids Other Names: Active Treatment

DIETARY_SUPPLEMENT

Placebo

Around 40g pea protein powder not containing dairy phospholipids Other Names: Placebo Treatment

Sponsors & Collaborators

  • Northumbria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-06-27
Completion
2025-06-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06663865 on ClinicalTrials.gov