Clinical ResearchTryptophan, Magnesium, Melissa and Lactuca Formulation

Improving Sleep and Daytime Function with Tryptophan, Magnesium, Melissa and Lactuca Formulation: An Exploratory Study in Adults with Sleep Disturbances

Franziska Schmitt , Ramon Weishaupt, Philipp KM Katumba, Dominic Vogt, Nadin Meyer, Michael Feld, Juliane Hellhammer

Journal of Nutritional Dietary Supplements

Purpose: Insufficient sleep is common and under-reported, linked to increased health risks. Many individuals seek alternatives to conventional medications, which often have adverse side effects.

Patients and Methods: This monocentric, single-arm, open-label exploratory study (Reg. No: NCT05748574) evaluated a granulate formulation containing 75 mg extract of the fresh herb of Lactuca sativa, 190 mg Melissa officinalis,120 mg L-Tryptophan, and 60 mg Magnesium in healthy adults with sleep disturbances. Conducted in Germany in 2023, 50 subjects consumed the formula nightly for 14 days. Outcomes were assessed via diaries, questionnaires, cognitive tests, wearables, saliva samples, and polysomnography (PSG) in a 10-subject subgroup. Statistical analysis compared pre- and post-treatment differences.

Results: Nightly awakenings reduced by 31% (p < 0.001) and early morning awakenings by 16% (p < 0.001). PSG data indicated a 28% increase in deep sleep (N3&N4, p > 0.05), a 70% rise in stage N4 (p = 0.042) and an 18% reduction in REM sleep (p > 0.05). The Apnea-Hypopnea index decreased by 26% (p = 0.11). Sleep quality (“Sleep questionnaire” SF-B/R index, primary outcome) improved by 14% (p = 0.003), with a 37% improvement in highly anxious individuals (p ≤ 0.001). Restedness increased by 22% in week 1 and 28% in week 2 (p ≤ 0.001). Psychological tension dropped by 21% and up to 29% (p ≤ 0.001). Daytime performance indicators included a 13% reduction in sleepiness and a 23% improvement in mood (p ≤ 0.014). Executive function showed a 13% improvement (p ≤ 0.001) on computerized tests (COMPASS). Findings from wearables, sleep quantity, and salivary biomarkers yielded an inconsistent picture. Adherence was high, with no serious adverse events reported.

Conclusion: The formulation was associated with observed improvements in subjective sleep quality—particularly among anxious individuals—as well as well-being and daytime function. Further confirmation through randomized placebo-controlled studies is warranted to further prove causality.

Clinical ResearchValeriana officinalis L. and Humulus lupulus L.

Sleep improving effects of a single dose administration of a valerian / hops fluid extract (Dormeasan)

W. Dimpfel and A. Suter
European Journal of Medical Research 2008
Abstract
Repetitive administrations of valerian/hops combinations have been widely used for self-administered therapy of sleep disturbances. This investigation focuses on the question if a single administration can be an effective sleep aid. Two parallel groups of n = 20 (verum) and n = 22 (placebo) were tested. Each subject spent two consecutive nights in the lab (reference night and medication night).
Medication consisted in giving verum or placebo to poor sleepers identified by a validated sleep questionnaire (Schlaffragebogen SF-B). Two ml of the liquid ex tract or similar smelling placebo were diluted in 50 ml water (flavoured with honey) and administered 15 minutes before EEG recording during the medication night.
The data analysis is based on the electrohypnogram – a method derived from a validated computer assisted automatic analysis for depth of sleep. Differences between the reference nights and medication nights were evaluated and tested for significance. Time spent in sleep (values of the sleep frequency index “SFx” of the electrohypnogram of 74% or lower) was significantly higher for the verum group in comparison to the placebo group (p<0.01). The difference with respect to time spent in deeper sleep (i.e. 68% and lower or 62% and lower) between reference and medication night was also statistically significant at p<0.01. This parameter correlated with the difference in quality of sleep between the two consecutive nights as derived from the sleep inventory SF-A sub-score (subjects evaluation) with r = 0.48 at p<0.0001.
The EEG derived parameter “sleep quantity” as calculated from the electrohypnogram proved superiority of the valerian/hops combination over placebo. Thus, the present investigation has shown evidence that a valerian/hops fluid extract can be used successfully using a single administration. Key words: Valerian, Hops, EEG, Sleep, Electrohypnogram