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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

Age 30-50y
-BMI 19.5-25 kg/m2 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 down-load/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 anonymized 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 study physician
-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 subjects themselves)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (PSQI)<br>The number of tones produced by the SmartSleep during deep sleep

Secondary Outcome Measures

Name	Time	Method
Sleep characteristics as measured by the SmartSleep,<br>Speed of cortisol increase in saliva following wake-up.<br>Stress level as measured by DASS-42 questionnaire<br>