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Melatonin-rich milk fortified with alpha s1 casein tryptic hydrolysate improves primary insomnia: a randomized placebo controlled trial

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Abstract

To determine the effect of a powdered skim milk product iNdream3; (Synlait Milk Ltd) on sleep in subjects with insomnia. A 9 week double blind randomized placebo controlled crossover trial was conducted in adults with primary insomnia (mean age 40 ± 14 years, 14/19 female, insomnia severity index >15,). Subjects were randomized to Product A: iNdream3 ‘NightMilk’ and Product B: ‘DayMilk’ for 3 weeks each with a 1 week washout. Total sleep time (TST), sleep efficiency (SE), sleep onset latency (SOL) and sleep quality were measured both subjectively (sleep diary and questionnaires) and objectively (actigraphy), over 1 week during baseline and active treatment arms. At the end of each arm subjects underwent home polysomnography (PSG). Consuming NightMilk compared with DayMilk improved sleep symptom questionnaire scores: Pittsburg Sleep Quality Index efficiency (+5.2 vs −0.4, p = 0.039), daytime dysfunction (−0.58 vs no change, p = 0.019), sleep related disturbance (−4.3 vs −1.5, p = 0.011) and SOL from diary, (−8 min vs +5 min, p = 0.045). Percent stage N3 sleep-PSG (+8 min vs −9 min, p = 0.004) and SE– by actigraphy (+2.3 vs +0.5 %, p = 0.004) increased. The number of awakenings–actigraphy improved (−1.8/night vs +1.5/night, p = 0.003). TST was not different between treatments. In subjects with primary insomnia consuming NightMilk produced small but significant improvements in insomnia symptoms, sleep efficiency, depth of sleep but did not increase TST. The size of the effects seen was similar in magnitude to other less well designed evaluations of non-pharmacological preparations but smaller than those reported for commonly prescribed pharmaceutical hypnotic products.

Clinical trials registry number

ACTRN12612000478819

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Acknowledgements

Mathew Johnson for assistance with patient recruitment, data entry and analysis. Dalice Sim for statistical advice.

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Authors and Affiliations

  1. WellSleep, Department of Medicine, University of Otago Wellington, PO Box 7343, Wellington, New Zealand

    Angela Campbell & Alister Neill

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  1. Angela Campbell
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  2. Alister Neill
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Correspondence to Angela Campbell.

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Funding

Funding was provided through an unrestricted research grant from Synlait Milk Ltd, Ingredia SA, and NZ Trade and Enterprise, with support from the Ministry for Primary Industries and DairyNZ through the Primary Growth Partnership.

Conflict of interest

No author has any conflict of interest to declare. No author received any direct financial payment or goods in kind from Synlait Milk Ltd.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the national research committee.

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Informed consent was obtained from all individual participants included in the study.

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Campbell, A., Neill, A. Melatonin-rich milk fortified with alpha s1 casein tryptic hydrolysate improves primary insomnia: a randomized placebo controlled trial. Sleep Biol. Rhythms 14, 351–360 (2016). https://doi.org/10.1007/s41105-016-0063-9

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  • DOI: https://doi.org/10.1007/s41105-016-0063-9

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