The effects of a nutritional supplement on sleep efficiency, sleep duration and stress, and the effect of audio intervention on deep sleep, in apparently healthy adults with sleep disturbances: a randomized controlled cross-over study

• Conditions: Slaapproblematiek; Insomnia; sleep disturbances

• Registration Number: NL-OMON48159
• Lead Sponsor: FrieslandCampina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

-Age 30-50 years -BMI 19.5 - 25 kg/m^2, as measured by the NIZO health and
lifestyle questionnaire -PSQI * 9 - willing and being able to consume a dairy
based product on a daily basis - Understand Dutch - Having access to the
internet and access to a mobile device for app download/function (phone or
tablet) - Apparently healthy according to the participant - Being available
during the study period (telephone and internet) - Willing to sign the written
informed consent - Accept use of all encoded data, including publication, and
the confidential use and storage of all encoded data.

Exclusion Criteria

-Use of medicines to improve sleep (e.g. Benzodiazepines and benzodiazepine
ago-nists such as Temazepam, Zolpidem, Lormetazepam and Zopiclon, and
Barbiturates such as Fenobarbital) or supplements (protein, vitamins, herbs) in
general which im-prove sleep as assessed by the principal investigator. - Sleep
apnea or other diagnosed sleep diseases - Being allergic to dairy products or
any of the ingredients of the product - Being intolerant for prebiotics - Those
involved in shift working - Having a serious risk on a jetlag at the time of
starting or during the study period: re-turn (*1 week before a treatment
period) from an intercontinental flight and from a time-zone with >3 hours
difference. - Pregnant or breastfeeding women - Being treated by psychologist
for sleep or burnout - Diseases of the respiratory tract that cause serious
sleep issues, as assed by the medical arts - No use of soft and hard drugs
during the study period. - Having a history of medical or surgical events that
may significantly affect the intes-tine and/or digestion (e.g including:
Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal
or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection; known or suspected gastrointes-tinal
disorders, colon or GI tract cancer - Mental status that is incompatible with
the proper conduct of the study (judgement is based on the personal view of the
researcher) - Alcohol consumption for men > 28 consumption units/week and
>4/day; for women: >21 units/week and >3/day - Reported weight loss or weight
gain of > 3 kg in the month prior to pre-study screen-ing, or intention to lose
weight during the study period - Reported slimming or medically prescribed diet
- Personnel of FrieslandCampina Research, NIZO and Philips Research, their
partners and their first and second degree relatives - Having a hearing
impairment (preventing hearing of tones of 80dB)'
- Peri- or postmenopausal women. Perimenopausal women will be defined based on
the criteria of hot flushed, irritability, irregular menstrual cycle and mood
swings (judgement is based on personal view of the subject themselves)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcomes are sleep quality as estimated by the Pittsburgh Sleep<br /><br>Quality Index (PSQI) questionnaire, and the effect of audio intervention<br /><br>(SmartSleep) on deep sleep.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are: sleep characteristics (total sleep time, REM, NREM,<br /><br>Wake ups After Sleep Onset, sleep onset/latency) as measured with the<br /><br>SmartSleep in monitoring modus. Stress, anxiety and depression are measured by<br /><br>the DASS-42 questionnaire, whereas also the rate of increase in wake-up<br /><br>cortisol levels will be monitored. Finally, tertiary outcomes are changes in<br /><br>microbiota composition and gut functionality as studied in faecal samples<br /><br>during the 1st and 2nd treatment periods.Daily a short questionnaire on<br /><br>bedtime, wake-up and some life-style habits has to be filled in. A short<br /><br>questionnaire on product tolerability will be offered together with the PSQI.</p><br>