Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Jun 27;13(7):2204.
doi: 10.3390/nu13072204.

The Effect of A Whey-Protein and Galacto-Oligosaccharides Based Product on Parameters of Sleep Quality, Stress, and Gut Microbiota in Apparently Healthy Adults with Moderate Sleep Disturbances: A Randomized Controlled Cross-Over Study

Affiliations
Randomized Controlled Trial

The Effect of A Whey-Protein and Galacto-Oligosaccharides Based Product on Parameters of Sleep Quality, Stress, and Gut Microbiota in Apparently Healthy Adults with Moderate Sleep Disturbances: A Randomized Controlled Cross-Over Study

Anne Schaafsma et al. Nutrients. .

Abstract

People experiencing sleep problems may benefit from nutrients supporting serotonin metabolism and stress reduction. We studied the effect of a dairy-based product (DP) containing protein, galacto-oligosaccharides, vitamins and minerals, on sleep quality, stress, and gut-microbiota. In a cross-over RCT (three weeks intervention; three weeks washout), adults (n = 70; 30-50 y) with sleep disturbances (Pittsburgh Sleep Quality Index (PSQI) ≥ 9) consumed products 1 h before bed-time. Sleep quality (PSQI) was measured weekly, stress at base- and end-line (Depression Anxiety Stress Scale and saliva cortisol). Fecal samples were collected in the 1st intervention period only. Compared to placebo (skimmed milk), PSQI was only lower at day 14 in the 2nd intervention period in intention-to-treat (ITT) (p = 0.017; n = 69) and per-protocol (PP) (p = 0.038; n = 64) analyses. Post-hoc analysis (modified-PP: n=47, with baseline PSQI ≥ 9, and endline day 14), however, showed a decrease in PSQI (-1.60 ± 2.53; p = 0.034). Early morning saliva cortisol decreased versus placebo (p = 0.045). Relative abundance of Bifidobacterium increased (p = 0.02). Redundancy analysis showed an inverse relationship between baseline microbiota composition and baseline PSQI (p = 0.046). Thus, although DP did not improve sleep quality in ITT and PP populations, it did in the modPP. DP reduced salivary cortisol and stimulated Bifidobacterium, which possibly is important for sleep improvement.

Keywords: GOS; galacto-oligosaccharides; microbiota; skimmed milk powder; sleep; stress; tryptophan; whey protein.

PubMed Disclaimer

Conflict of interest statement

A.S., L.M., and J.V. were employed by FrieslandCampina (sponsor of the study). Other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
The recruitment–allocation–analysis flow diagram. DP, based on CONSORT 2010 but adapted for cross-over design: dairy-based test product; PSQI: Pittsburgh Sleep Quality Index.
Figure 2
Figure 2
Changes in PSQI from baseline to day 14, for the ITT, PP, and modPP populations. Box-Whisker plot showing median, first (Q1) and third (Q3) quartile, and mean value (X). Whiskers are 1.5 times inter quartile range (IQR = Q3–Q1)) or maximum/minimum values when these are within the 1.5 IQR range. Outliers (beyond the 1.5 times IQR) are presented as single dots. p-values are based on independent-samples t-test. DP: Dairy-based test product. Placebo: skimmed milk. PSQI: Pittsburgh Sleep Quality Index.
Figure 3
Figure 3
Bivariate analyses show an increase in Bifidobacterium over time (2log ratio of relative abundance at day 21 and day 0) for the DP and no change for placebo group (ITT) (p = 0.02). Boxplots are displayed as Tukey whiskers. DP: Dairy-based test product. Placebo: skimmed milk.

References

    1. Chattu V., Manzar M., Kumary S., Burman D., Spence D., Pandi-Perumal S. The Global Problem of Insufficient Sleep and Its Serious Public Health Implications. Healthcare. 2018;7:1. doi: 10.3390/healthcare7010001. - DOI - PMC - PubMed
    1. Gulia K.K., Kumar V.M. Sleep disorders in the elderly: A growing challenge. Psychogeriatrics. 2018;18:155–165. doi: 10.1111/psyg.12319. - DOI - PubMed
    1. Mander B.A., Winer J.R., Jagust W.J., Walker M.P. Sleep: A novel mechanistic pathway, biomarker, and treatment target in the pathology of Alzheimers’s disease? Trends Neurosci. 2016;39:552–566. doi: 10.1016/j.tins.2016.05.002. - DOI - PMC - PubMed
    1. Wahl S., Engelhardt M., Schaupp P., Lappe C., Ivanov I.V. The inner clock—Blue light sets the human rhythm. J. Biophotonics. 2019;12:1–14. doi: 10.1002/jbio.201900102. - DOI - PMC - PubMed
    1. Watson E.J., Coates A.M., Kohler M., Banks S. Caffeine consumption and sleep quality in Australian adults. Nutrients. 2016;8:E479. doi: 10.3390/nu8080479. - DOI - PMC - PubMed

Publication types

LinkOut - more resources