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

NCT06663865 | Not Yet Recruiting

• 1 other identifier: 66CH3
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Sleep; Daytime function; diurnal cortisol; Morning alertness; Evening alertness; dreams

Outcome Measures

Primary Outcomes (1)

• Sleep quality - Objective sleep quality measured through actigraphy sleep watches

  Average scores across 7 days. Scores for sleep onset, total sleep time, wake after sleep onset, awakenings, average awakening, and efficiency of sleep will be averaged

  prior to (baseline) and following chronic dose of intervention at 6 weeks and 12 weeks.

Secondary Outcomes (18)

• Acute self-reported state anxiety via the Anticipated Versus Experienced Demand Questionnaire

  prior to (baseline) and following 6- and 12-week chronic intervention

• Cognitive and somatic anxiety via the Anticipated Versus Experienced Demand Questionnaire

  prior to (baseline) and following 6- and 12-week chronic intervention

• Anticipated and Experienced Demand via the Anticipated Versus Experienced Demand Questionnaire

  prior to (baseline) and following 6- and 12-week chronic intervention

• Perceived Stress via the Perceived Stress Scale:

  prior to (baseline) and following 6- and 12-week chronic intervention

• Depression, Anxiety and Stress Scale (DASS-21)

  Prior to (baseline) and following 6- and 12-week chronic intervention

Other Outcomes (1)

• Exploratory outcome: Changes to dream recall

  prior to (baseline) and following 6- and 12-week chronic intervention

Study Arms (2)

Bioactive whey protein concentrate containing dairy phospholipids

EXPERIMENTAL

40g pre weighed powder to be mixed with 350ml of water. Consumed one daily for 12 weeks alongside their fattiest meal of the day.

Dietary Supplement: Active

Placebo Powder

PLACEBO COMPARATOR

Placebo powder matched for macro-nutrient and caloric content containing pea protein around 40g powder mixed with 350ml of water consumed once daily for 12 weeks alongside fattiest meal of the day.

Dietary Supplement: Placebo

Interventions

Active DIETARY_SUPPLEMENT

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

Bioactive whey protein concentrate containing dairy phospholipids

Placebo DIETARY_SUPPLEMENT

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

Placebo Powder

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must self-assess themselves as being in good health.
• Participants must be aged 25 to 49 years at the time of giving consent.
• Participants must be a native speaker of English or fluent in English

You may not qualify if:

• Have any pre-existing medical conditions/illness which will impact taking part in the study. There may be other, unforeseen exceptions and these will be considered on a case-by-case basis: i.e., participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance. It is therefore worth discussing any medical conditions with the researcher prior to booking appointments
• Are currently taking any prescription medications (NOTE the explicit exceptions to this are contraceptive treatments for female participants, and those taking "as needed" in the treatment of asthma and/or hay fever. There may be other instances of medication use which, where no interaction with the active treatment is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening
• Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg). NOTE: that we must measure this in the lab using our blood pressure monitors and can only use our measurements to assess eligibility rather than home or GP readings
• Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2.
• Are pregnant, seeking to become pregnant or lactating.
• Have learning and/or behavioural difficulties such as dyslexia or ADHD.
• Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
• Smoke tobacco or vape nicotine or use nicotine replacement products (if you have recently quit smoking or using replacements you must have stopped using them altogether for a period of 3 months before participating in this study)
• Have excessive caffeine intake (500 mg per day). Note: This will be calculated at screening but feel free to query this with the researcher prior to attendance
• Have relevant food allergies/ intolerance/ sensitivities
• Have taken antibiotics within the past 4 weeks.
• Have taken dietary supplements e.g., vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement wash out prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised. Please discuss with the researcher if unsure. NOTE: we would never advise stopping supplements prescribed by your doctor e.g., iron, calcium etc., only those you use out of choice)
• Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
• Are unable to complete all of the study assessments (this will be assessed by the researcher at the training appointment)
• Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks

Sponsors & Collaborators

• Northumbria University: lead

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Philippa A Jackson, PhD

CONTACT

01912274468; philippa.jackson@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment will be blinded according to the randomisation schedule by a research who has no other involvement in the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, placebo-controlled, parallel groups design.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: October 28, 2024
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share