Objectives: Evaluate the effects of supplementing with a whey protein naturally rich in phospholipids on stress and anxiety responses in adults with intermittent anxiety. Methods: This pilot study used an open-label design. Twenty-four adults who reported regular and frequent episodes of intermittent anxiety were enrolled in the study, whereby they consumed the test supplement daily in the morning for 4 weeks. Prior to the study, participants identified a primary daily stressor, and up to 3 additional stressors, that caused them repeated anxiety. Participants answered questionnaires at baseline and weekly during 4 weeks supplementation. The questionnaires included Total Anxiety Score (from Generalized Anxiety Disorder (GAD-7) and Stressor Discomfort (SD-9)), Overall Anxiety Severity and Impairment Scale (OASIS) and Leeds Sleep Questionnaire. The supplement was a vanilla-flavored powdered shake, provided in one-per-day dosed sachets. Each serve provided 13g protein from whey and 1.49g phospholipids that naturally occur in milk. Results: 23 participants completed the study with a 92.4% compliance rate to the supplementation. A significant reduction in Total Anxiety Score was found from baseline to week 4 for the primary stressor (-56.98%, P=0.000), secondary stressor (-54.20%, P=0.0005), and tertiary stressor (-62.87%, P=0.0022). Similarly, the OASIS scores found a significant reduction in measures of anxiety from baseline to week 4 (-53.88, P=0.0001). Concurrently, there were significant improvements in sleep evaluation measures over the same period (26.17%, P=0.0180), with participants noting they fell asleep more easily (48.42% improvement, P=0.0048) and felt more alert on waking up (69.12% improvement, P=0.0089). Conclusions: The supplement based on milk-based phospholipids was formulated with the goal of providing a natural solution to reduce situational anxiety. The results from this clinical trial have confirmed that the product provided a rapid reduction of anxiety after short-term consumption, with subsequent improvements in sleep. This preliminary investigation supports further investigation of supplemental MFGM for people who experience frequent episodes of anxiety and disruptive sleep patterns and quality. Funding Sources: This study was funded by a research grant from Dairy Business Innovation Alliance and Milk Specialties Global.
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Ormond et al. (2024) studied this question.
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